Are Vaccine Boosters Widely Needed? Some Federal Advisers Have Misgivings
“In our hearts, I think people don’t quite agree with this notion of a booster dose,” said one leading vaccine expert. (Source: NYT Health)
Source: NYT Health - October 25, 2021 Category: Consumer Health News Authors: Apoorva Mandavilli Tags: your-feed-science Vaccination and Immunization Coronavirus (2019-nCoV) Advisory Committee on Immunization Practices Centers for Disease Control and Prevention Food and Drug Administration Moderna Inc BioNTech SE Pfizer Inc Johnson & Source Type: news

F.D.A. Says Pfizer Vaccine ’s Benefits Outweigh Key Risks in Children 5 to 11
The findings could add momentum for F.D.A. authorization of the pediatric dose, perhaps as early as next week, a long-awaited development that would affect 28 million children. (Source: NYT Health)
Source: NYT Health - October 24, 2021 Category: Consumer Health News Authors: Sharon LaFraniere and Noah Weiland Tags: Clinical Trials Coronavirus (2019-nCoV) Vaccination and Immunization Children and Childhood Coronavirus Risks and Safety Concerns Pfizer Inc BioNTech SE Food and Drug Administration Source Type: news

COVID vaccine experiment causes monstrous spike in vaccine injuries and deaths, serious adverse events under-reported by a factor of eight
(Natural News) The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) are legally required to collect and report accurate pharmacovigilance data in regard to every vaccine on the market. Pharmacovigilance is a necessary system of checks and balances that monitors activities relating to the detection, assessment, safety, understanding and prevention of... (Source: NaturalNews.com)
Source: NaturalNews.com - October 24, 2021 Category: Consumer Health News Source Type: news

FDA Says Pfizer COVID-19 Vaccine Looks Effective for Young Kids
Federal health regulators said late Friday that kid-size doses of Pfizer’s COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children and caused no unexpected safety issues, as the U.S. weighs beginning vaccinations in youngsters. The Food and Drug Administration posted its analysis of Pfizer’s data ahead of a public meeting next week to debate whether the shots are ready for the nation’s roughly 28 million children ages 5 to 11. The agency will ask a panel of outside vaccine experts to vote on that question. In their analysis, FDA scientists concluded that...
Source: TIME: Health - October 23, 2021 Category: Consumer Health News Authors: LAURAN NEERGAARD and MATTHEW PERRONE / AP Tags: Uncategorized COVID-19 wire Source Type: news

REVOLVING DOOR: All three FDA-authorized Operation Warp Speed vaccine corporations employ former FDA commissioners
(Natural News) The revolving door between Big Pharma and the federal government is once again on display after it was revealed that all three vaccine corporations pushing “Operation Warp Speed” injections for the Wuhan coronavirus (Covid-19) have former U.S. Food and Drug Administration (FDA) commissioners on their respective payrolls. Scott Gottlieb, a corrupt pharmaceutical baron... (Source: NaturalNews.com)
Source: NaturalNews.com - October 22, 2021 Category: Consumer Health News Source Type: news

FDA approves Roche ’s Susvimo, a first-of-its-kind therapeutic approach for neovascular or “wet” age-related macular degeneration (nAMD)
Basel, 22 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo ™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with neovascular or “wet” age-related macular degeneration (nAMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Neovascular AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month.1,2,3,4 Susvimo, previously called Port Delivery System with ranibizum...
Source: Roche Media News - October 22, 2021 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Susvimo, a first-of-its-kind therapeutic approach for neovascular or “wet” age-related macular degeneration (nAMD)
Basel, 22 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo ™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with neovascular or “wet” age-related macular degeneration (nAMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Neovascular AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month.1,2,3,4 Susvimo, previously called Port Delivery System with ranibizum...
Source: Roche Investor Update - October 22, 2021 Category: Pharmaceuticals Source Type: news

Pfizer Says Its COVID-19 Vaccine Appears More Than 90% Effective in Kids
Kid-size doses of Pfizer’s COVID-19 vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, according to study details released Friday as the U.S. considers opening vaccinations to that age group. The shots could begin in early November — with the first children in line fully protected by Christmas — if regulators give the go-ahead. Details of Pfizer’s study were posted online. The Food and Drug Administration was expected to post its independent review of the company’s safety and effectiveness data later in the day. Advisers to the FDA will pub...
Source: TIME: Health - October 22, 2021 Category: Consumer Health News Authors: Lauran Neergaard and Matthew Perrone / AP Tags: Uncategorized COVID-19 wire Source Type: news

Roche ’s VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab)
Basel, 22 October 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA PD-L1 (SP263) Assay in non- small cell lung cancer (NSCLC) as a companion diagnostic test for Tecentriq, advancing the company's commitment to guide clinical decision making through innovative, high quality assays that improve patient access to personalized healthcare. (Source: Roche Media News)
Source: Roche Media News - October 22, 2021 Category: Pharmaceuticals Source Type: news

Roche ’s VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab)
Basel, 22 October 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA PD-L1 (SP263) Assay in non- small cell lung cancer (NSCLC) as a companion diagnostic test for Tecentriq, advancing the company's commitment to guide clinical decision making through innovative, high quality assays that improve patient access to personalized healthcare. (Source: Roche Investor Update)
Source: Roche Investor Update - October 22, 2021 Category: Pharmaceuticals Source Type: news

C.D.C. Panel Endorses Moderna and J. & J. Boosters for Millions
Recipients of the Moderna and the J.&J. vaccines may receive extra doses, although the shots continue to prevent illness and death. (Source: NYT Health)
Source: NYT Health - October 22, 2021 Category: Consumer Health News Authors: Apoorva Mandavilli Tags: Coronavirus (2019-nCoV) Vaccination and Immunization Advisory Committee on Immunization Practices Centers for Disease Control and Prevention Food and Drug Administration Johnson & Moderna Inc BioNTech SE Pfizer Inc Source Type: news

Pfizer says COVID-19 vaccine more than 90% effective in kids
The Food and Drug Administration is expected to post its initial review of the company's safety and effectiveness data later Friday. Next week, advisers to the FDA will publicly debate the evidence. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 22, 2021 Category: Pharmaceuticals Source Type: news

CDC Authorizes Boosters of Moderna and Johnson & Johnson COVID-19 Vaccines
Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), authorized booster doses of COVID-19 vaccines for certain groups. Walensky followed the advice of a CDC expert panel, which recommended the boosters in in two unanimous votes earlier in the day. The 15-member Advisory Committee on Immunization Practices (ACIP) advised that anyone who was initially vaccinated with the Moderna shot get a booster at least six months later, and that J&J-Janssen recipients receive a booster at least two months after their initial vaccination. The endorsement follows a similar decision from the Food and ...
Source: TIME: Health - October 21, 2021 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 Source Type: news

CDC Authorizes Boosters of Moderna and Johnson & Johnson COVID-19 Vaccines
Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), authorized booster doses of COVID-19 vaccines for certain groups. Walensky followed the advice of a CDC expert panel, which recommended the boosters in in two unanimous votes earlier in the day. The 15-member Advisory Committee on Immunization Practices (ACIP) advised that anyone who was initially vaccinated with the Moderna shot get a booster at least six months later, and that J&J-Janssen recipients receive a booster at least two months after their initial vaccination. The endorsement follows a similar decision from the Food and ...
Source: TIME: Health - October 21, 2021 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 Source Type: news

C.D.C. Panel Meets on Boosters and'Mix-and-Match' Strategy
The panel heard that in adults under 65, even those with chronic conditions, the Moderna vaccine remained highly protective against severe illness, and showed only a small decline over time, if at all. (Source: NYT Health)
Source: NYT Health - October 21, 2021 Category: Consumer Health News Authors: Apoorva Mandavilli Tags: Coronavirus (2019-nCoV) Vaccination and Immunization Advisory Committee on Immunization Practices Centers for Disease Control and Prevention Food and Drug Administration Johnson & Moderna Inc BioNTech SE Pfizer Inc Source Type: news

Pregnant? Breastfeeding? Better Drug Information Is Coming
The Food and Drug Administration is helping women and their health care providers to learn more about the effects of medicines during pregnancy and breastfeeding. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 21, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

F.D.A. Authorizes Moderna and Johnson & Johnson Booster Shots
The agency will also allow vaccine recipients to pick which vaccine they want as a booster, endorsing a mix-and-match approach. (Source: NYT)
Source: NYT - October 21, 2021 Category: American Health Authors: Noah Weiland and Sharon LaFraniere Tags: Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) Food and Drug Administration Johnson & Moderna Inc Pfizer Inc BioNTech SE United States Politics and Government Source Type: news

Mixing covid vaccines? What you need to know about mix-and-match booster shots.
Under the Food and Drug Administration's new recommendations, eligible patients could get any of the three available booster doses, regardless of which shot they got first. (Source: Washington Post: To Your Health)
Source: Washington Post: To Your Health - October 21, 2021 Category: Consumer Health News Authors: Katie Shepherd Source Type: news

C.D.C. Panel to Debate Boosters and'Mix-and-Match' Strategy
After the F.D.A. issued its authorization of additional doses of vaccines as boosters, it passed the baton to experts advising the Centers for Disease Control and Prevention. (Source: NYT Health)
Source: NYT Health - October 21, 2021 Category: Consumer Health News Authors: Apoorva Mandavilli Tags: Coronavirus (2019-nCoV) Vaccination and Immunization Advisory Committee on Immunization Practices Centers for Disease Control and Prevention Food and Drug Administration Johnson & Moderna Inc BioNTech SE Pfizer Inc Source Type: news

FDA takes additional actions on the use of a booster dose for COVID-19 vaccines
Today, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows: (Source: World Pharma News)
Source: World Pharma News - October 21, 2021 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

FDA authorizes booster doses of Moderna and Johnson & Johnson vaccines, says mix and match OK
The US Food and Drug Administration authorized booster doses of both Covid-19 vaccines made by Moderna and Johnson& Johnson Wednesday and also said any of the three authorized vaccines could be used as a booster is a "mix and match" approach. (Source: CNN.com - Health)
Source: CNN.com - Health - October 21, 2021 Category: Consumer Health News Source Type: news

FDA approves booster shot of Moderna and Johnson & Johnson vaccines
The U.S. Food and Drug Administration (FDA) authorized booster shots for the Moderna and Johnson & Johnson COVID-19 vaccines on Wednesday. (Source: the Mail online | Health)
Source: the Mail online | Health - October 21, 2021 Category: Consumer Health News Source Type: news

FDA Authorizes Moderna and J & J Booster Shots
The Food and Drug Administration (FDA) today followed the advice of its advisory committee and recommended booster shots of COVID-19 vaccines from Moderna and Johnson&Johnson-Janssen. The agency also authorized mixing or matching booster doses, meaning that people can either get another dose of the same vaccine they originally received, or get a booster with a different vaccine. More than 150 million doses of the Moderna vaccine and 15 million of the J&J-Janssen vaccine have been administered in the U.S. In a briefing discussing the agency’s decision, acting FDA director Dr. Janet Woodcock said the primary re...
Source: TIME: Health - October 20, 2021 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 Source Type: news

Johnson & Johnson COVID-19 Vaccine Booster Shot Authorized for Emergency Use by U.S. FDA
NEW BRUNSWICK, N.J., October 20, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine. The Johnson & Johnson booster shot will be the same formulation and dosage as the primary shot. The EUA follows a unanimous recomme...
Source: Johnson and Johnson - October 20, 2021 Category: Pharmaceuticals Tags: Latest News Source Type: news

FDA greenlights Moderna boosters, mix-and-match shots
The U.S. Food and Drug Administration has given the O.K. to Covid-19 vaccine "booster" shots made by Cambridge biotech Moderna Inc. Moderna (Nasdaq: MRNA) is now able to make and distribute boosters — third shots identical to each of the first two in the series, but half the amount — for patients 65 and older, adults with underlying medical conditions and adults who are at a high risk for Covid-19 because of their occupati ons or time in institutional settings. The decision comes a few days… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - October 20, 2021 Category: American Health Authors: Rowan Walrath Source Type: news

FDA greenlights Moderna boosters, mix-and-match shots
The U.S. Food and Drug Administration has given the O.K. to Covid-19 vaccine "booster" shots made by Cambridge biotech Moderna Inc. Moderna (Nasdaq: MRNA) is now able to make and distribute boosters — third shots identical to each of the first two in the series, but half the amount — for patients 65 and older, adults with underlying medical conditions and adults who are at a high risk for Covid-19 because of their occupati ons or time in institutional settings. The decision comes a few days… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 20, 2021 Category: Biotechnology Authors: Rowan Walrath Source Type: news

FDA greenlights Moderna boosters, mix-and-match shots
The U.S. Food and Drug Administration has given the O.K. to Covid-19 vaccine "booster" shots made by Cambridge biotech Moderna Inc. Moderna (Nasdaq: MRNA) is now able to make and distribute boosters — third shots identical to each of the first two in the series, but half the amount — for patients 65 and older, adults with underlying medical conditions and adults who are at a high risk for Covid-19 because of their occupati ons or time in institutional settings. The decision comes a few days… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - October 20, 2021 Category: American Health Authors: Rowan Walrath Source Type: news

FDA greenlights Moderna boosters, mix-and-match shots
The U.S. Food and Drug Administration has given the O.K. to Covid-19 vaccine "booster" shots made by Cambridge biotech Moderna Inc. Moderna (Nasdaq: MRNA) is now able to make and distribute boosters — third shots identical to each of the first two in the series, but half the amount — for patients 65 and older, adults with underlying medical conditions and adults who are at a high risk for Covid-19 because of their occupati ons or time in institutional settings. The decision comes a few days… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 20, 2021 Category: Biotechnology Authors: Rowan Walrath Source Type: news

Sales of Biogen's Alzheimer's Drug Fall Short of Expectations
The drug, Aduhelm, brought in $300,000 in revenue in its first full three months of availability. The company expects the drug to generate minimal revenue for the rest of the year. (Source: NYT Health)
Source: NYT Health - October 20, 2021 Category: Consumer Health News Authors: Rebecca Robbins Tags: Drugs (Pharmaceuticals) Aduhelm (Drug) Alzheimer ' s Disease Medicare Biogen Inc Cleveland Clinic Blue Cross and Blue Shield Assn Food and Drug Administration Mount Sinai Medical Center Veterans Affairs Department Vounatsos, Michel Source Type: news

FDA green lights Methodist Healthcare for use of new heart transplant technology
San Antonio-based Methodist Healthcare ’s flagship hospital is the first such facility in Texas cleared by the Food and Drug Administration for commercial use of a new technology that could revolutionize heart transplantation. Its use of that device is also expected to widen the pool of potential donors and could position Methodist as an even bigger player in the organ transplant field. That new technology is Massachusetts-based TransMedics Inc.’s Organ Care System, engineered to emulate the… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 20, 2021 Category: Biotechnology Authors: W. Scott Bailey Source Type: news

Sales of Biogen ’s costly new Alzheimer’s drug fall far short of expectations.
The drug, Aduhelm, brought in $300,000 in revenue in its first full three months of availability. The company expects the drug to generate minimal revenue for the rest of the year. (Source: NYT Health)
Source: NYT Health - October 20, 2021 Category: Consumer Health News Authors: Rebecca Robbins Tags: Drugs (Pharmaceuticals) Aduhelm (Drug) Alzheimer ' s Disease Medicare Biogen Inc Cleveland Clinic Blue Cross and Blue Shield Assn Food and Drug Administration Mount Sinai Medical Center Veterans Affairs Department Vounatsos, Michel Source Type: news

Biden ’s Plan to Vaccinate Young Children 5 to 11
White House officials, anticipating the approval of coronavirus shots for 5- to 11-year-olds within weeks, will rely on doctors, clinics and pharmacies instead of mass inoculation sites. (Source: NYT Health)
Source: NYT Health - October 20, 2021 Category: Consumer Health News Authors: Katie Rogers Tags: Children and Childhood Vaccination and Immunization United States Politics and Government Coronavirus (2019-nCoV) Biden, Joseph R Jr Food and Drug Administration Centers for Disease Control and Prevention Source Type: news

Schools and Pediatricians Will Be Key to Biden ’s Childhood Vaccine Rollout
The White House outlined its COVID-19 plan to vaccinate younger children which would focus on smaller doses administered with smaller needles if the shots are authorized by regulators. “We will be ready to get shots in arms,” President Joe Biden’s COVID-19 response coordinator, Jeff Zients, said Wednesday during a White House briefing on the plan, which includes supporting vaccination by primary care doctors and in pharmacies and schools. The U.S. has ordered enough supply to vaccinate all kids 5 to 11, the White House said in a statement Wednesday. The vaccination campaign for kids would differ from the ...
Source: TIME: Health - October 20, 2021 Category: Consumer Health News Authors: Josh Wingrove / Bloomberg Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news

Scientists Successfully Attached a Pig Kidney to Human For the First Time
Scientists temporarily attached a pig’s kidney to a human body and watched it begin to work, a small step in the decades-long quest to one day use animal organs for life-saving transplants. Pigs have been the most recent research focus to address the organ shortage, but among the hurdles: A sugar in pig cells, foreign to the human body, causes immediate organ rejection. The kidney for this experiment came from a gene-edited animal, engineered to eliminate that sugar and avoid an immune system attack. Surgeons attached the pig kidney to a pair of large blood vessels outside the body of a deceased recipient so they cou...
Source: TIME: Health - October 20, 2021 Category: Consumer Health News Authors: Carla K. Johnson / AP Tags: Uncategorized Research wire Source Type: news

Scientists Successfully Attached a Pig Kidney to Human For the First Time
Scientists temporarily attached a pig’s kidney to a human body and watched it begin to work, a small step in the decades-long quest to one day use animal organs for life-saving transplants. Pigs have been the most recent research focus to address the organ shortage, but among the hurdles: A sugar in pig cells, foreign to the human body, causes immediate organ rejection. The kidney for this experiment came from a gene-edited animal, engineered to eliminate that sugar and avoid an immune system attack. Surgeons attached the pig kidney to a pair of large blood vessels outside the body of a deceased recipient so they cou...
Source: TIME: Science - October 20, 2021 Category: Science Authors: Carla K. Johnson / AP Tags: Uncategorized Research wire Source Type: news

U.S. greenlights mixed doses for COVID-19 vaccine booster shots
The U.S. Food and Drug Administration (FDA) on Wednesday authorized booster doses of COVID-19 vaccines from Moderna and Johnson & Johnson, and said Americans can choose a shot that is different than their original inoculation. (Source: CBC | Health)
Source: CBC | Health - October 20, 2021 Category: Consumer Health News Tags: News/World Source Type: news

FDA: Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
Notice of proposed rule from the Food and Drug Administration (FDA) proposing to establish a regulatory category for over-the-counter (OTC) hearing aids to improve access to hearing aid technology for people 18 years old or older. This notice is also proposing related amendments to update the regulatory framework for hearing aids. Includes considerations for hearing aid access in rural and underserved communities. Comments on the proposed rule are due by January 18, 2022. Comments on the information collection are due by November 19, 2021. (Source: Federal Register updates via the Rural Assistance Center)
Source: Federal Register updates via the Rural Assistance Center - October 20, 2021 Category: Rural Health Source Type: news

FDA Moves to Make Some Hearing Aids Available Without a Prescription
The proposed rule could make it easier for Americans with mild to moderate hearing impairments to get the devices. (Source: NYT Health)
Source: NYT Health - October 19, 2021 Category: Consumer Health News Authors: Emily Anthes Tags: your-feed-science Hearing Aids Ears and Hearing United States Politics and Government Medical Devices Regulation and Deregulation of Industry Food and Drug Administration Source Type: news

Mix-and-Match Covid Boosters: Why They Just Might Work
The F.D.A. may authorize booster shots of vaccines different from the ones that Americans originally received. The science behind the move is promising. (Source: NYT Health)
Source: NYT Health - October 19, 2021 Category: Consumer Health News Authors: Carl Zimmer Tags: Clinical Trials Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) Antibodies Immune System Johnson & Moderna Inc Pfizer Inc Food and Drug Administration Source Type: news

Johnson & Johnson Hike 2021 Profit Forecast as COVID-19 Vaccine Sales Grow
Sales of the cancer treatment Darzalex helped Johnson & Johnson deliver better-than-expected third-quarter earnings, while COVID-19 fueled vaccine revenue and had more customers reaching for Tylenol. The world’s biggest maker of health care products hiked its 2021 earnings forecast after saying Tuesday that net income climbed 3% to $3.67 billion in the recently completed quarter. Sales of the company’s single-shot COVID-19 vaccine started to pick up in the quarter and nearly doubled what it brought in during the first half of 2021. J&J also said that sales of over-the-counter drugs, which do not need pr...
Source: TIME: Health - October 19, 2021 Category: Consumer Health News Authors: TOM MURPHY/AP Tags: Uncategorized biztech2030 Vaccines wire Source Type: news

FDA planning to allow mix-and-match Covid-19 vaccine boosters
The US Food and Drug Administration is planning on allowing Americans to receive a different coronavirus vaccine for their booster shots... (Source: Reuters: Health)
Source: Reuters: Health - October 19, 2021 Category: Consumer Health News Source Type: news

FDA may approve people to 'mix and match' booster shots, report says: COVID-19 updates
The Food and Drug Administration may approve administering booster shots that are different from recipients' original COVID vaccine.... (Source: Reuters: Health)
Source: Reuters: Health - October 19, 2021 Category: Consumer Health News Source Type: news

United Therapeutics hits speed bump in its quest for new drug approval
The company applied in April for Food and Drug Administration approval to sell the new product. Now that process could take a bit more time. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - October 19, 2021 Category: Pharmaceuticals Authors: Sara Gilgore Source Type: news

United Therapeutics hits speed bump in its quest for new drug approval
Four months after seeking federal approval to start selling its latest product, United Therapeutics Corp. (NASDAQ: UTHR) has its response — and it's not exactly all the Silver Spring drugmaker had hoped. The company said Monday that the Food and Drug Administration has declined to give its stamp of approval for Tyvaso DPI, an inhaler that dispenses a dry powder form of the pulmonary arterial hypertension (PAH) drug, treprostinil. T he company had sought the agency’s green light in April to take… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 19, 2021 Category: Biotechnology Authors: Sara Gilgore Source Type: news

FDA will allow fully vaccinated Americans to mix and match COVID-19 vaccine booster shots
The U.S. Food and Drug Administration (FDA) will allow fully vaccinated Americans to 'mix and match' COVID-19 vaccines and booster shots. (Source: the Mail online | Health)
Source: the Mail online | Health - October 19, 2021 Category: Consumer Health News Source Type: news

FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
Second Interchangeable Biosimilar Product Approved by Agency SILVER SPRING, Md., Oct. 18, 2021 -- (Healthcare Sales & Marketing Network) -- The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inf... Biopharmaceuticals, Generics, FDA Boehringer Ingelheim, Cyltezo, Humira, adalimumab, biosimilar (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 18, 2021 Category: Pharmaceuticals Source Type: news

F.D.A. to Allow ‘Mix and Match’ Approach for Covid Booster Shots
The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson& Johnson vaccines. (Source: NYT Health)
Source: NYT Health - October 18, 2021 Category: Consumer Health News Authors: Sharon LaFraniere and Noah Weiland Tags: Food and Drug Administration Centers for Disease Control and Prevention Vaccination and Immunization Drugs (Pharmaceuticals) Johnson & Moderna Inc Pfizer Inc Coronavirus (2019-nCoV) National Institutes of Health Regulation and Deregula Source Type: news

Study: Medicare spends millions on cancer treatments without clinical benefit
Medicare spent nearly $600 million over a three-year period for cancer care involving four Food and Drug Administration-approved drugs later found to provide no clinical benefit for certain forms of the disease. (Source: Health News - UPI.com)
Source: Health News - UPI.com - October 18, 2021 Category: Consumer Health News Source Type: news

What Colin Powell ’s COVID-19 Death Says About the Current State of the Pandemic
The death of Colin Powell, an 84-year-old former four-star general who served as Chairman of the Joint Chiefs of Staff under U.S. President George H.W. Bush and Secretary of State under President George W. Bush and is perhaps best known for his role in bringing the U.S. into its second war in Iraq, is a high-profile reminder of a grim reality: COVID-19 is not just a pandemic of the unvaccinated, as current president Joe Biden likes to say, but a pandemic of the elderly, too. From early on in the pandemic, we’ve known the virus disproportionately kills older people, and the overall data make that pretty clear: About 5...
Source: TIME: Health - October 18, 2021 Category: Consumer Health News Authors: Alex Fitzpatrick Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news

United Therapeutics hits speed bump in its quest for new drug approval
The company applied in April for Food and Drug Administration approval to sell the new product. Now that process could take a bit more time. (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - October 18, 2021 Category: Health Management Authors: Sara Gilgore Source Type: news