FDA Reportedly Hopes To Fully Approve Pfizer ’s Covid Vaccine By Labor Day
The Food and Drug Administration says it ’s engaged in an “all-hands-on-deck approach” to granting full approval to Pfizer’s coronavirus vaccine. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - August 4, 2021 Category: Pharmaceuticals Authors: Joe Walsh, Forbes Staff Tags: Business /business Innovation /innovation Healthcare /healthcare Breaking breaking-news Source Type: news

F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month
The Food and Drug Administration ’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops. (Source: NYT Health)
Source: NYT Health - August 3, 2021 Category: Consumer Health News Authors: Sharon LaFraniere and Noah Weiland Tags: Vaccination and Immunization Drugs (Pharmaceuticals) BioNTech SE Centers for Disease Control and Prevention Food and Drug Administration Pfizer Inc Moderna Inc Johnson & Coronavirus (2019-nCoV) United States Politics and Government Source Type: news

US FDA grants Priority Review to Roche ’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
Basel, 3 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%, as determined by an FDA-appro ved test. The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and ef...
Source: Roche Media News - August 3, 2021 Category: Pharmaceuticals Source Type: news

US FDA grants Priority Review to Roche ’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
Basel, 3 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%, as determined by an FDA-appro ved test. The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and ef...
Source: Roche Investor Update - August 3, 2021 Category: Pharmaceuticals Source Type: news

FDA clears RealView's Holoscope-i holographic system
The U.S. Food and Drug Administration (FDA) has cleared Israeli 3D holographi...Read more on AuntMinnie.comRelated Reading: Is virtual reality in radiology becoming a reality? Philips, RealView wrap up 3D holographic study (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - August 2, 2021 Category: Radiology Source Type: news

FDA just ordered covid vaccine manufacturers to use more children for medical experiments and spike protein jabs
(Natural News) The U.S. Food and Drug Administration (FDA) is calling on Pfizer and Moderna to recruit more children into their respective Wuhan coronavirus (Covid-19) “vaccine” trials. Children between the ages of five and 11 are needed, the FDA insists, to determine whether a “rare” side effect involving heart inflammation is more common among young... (Source: NaturalNews.com)
Source: NaturalNews.com - August 2, 2021 Category: Consumer Health News Source Type: news

Alkermes Receives FDA Fast Track Designation for Nemvaleukin Alfa for the Treatment of Mucosal Melanoma
DUBLIN, Aug. 2, 2021 -- (Healthcare Sales & Marketing Network) -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, inves... Biopharmaceuticals, Oncology, FDA Alkermes, nemvaleukin, mucosal melanoma (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 2, 2021 Category: Pharmaceuticals Source Type: news

Almost Every Doctor Recommends Sunscreen. So Why Don ’t We Know More About Its Safety?
Each year, as Memorial Day approaches, Holly Thaggard braces herself for the headlines. About how sunscreen may be damaging coral reefs. About the possible flammability of spray-on sunscreen. Headlines—as there were this year—about how sunscreen contains chemicals that could harm your health. “This has happened every single year for the last decade of my life,” says Thaggard, founder of Texas-based Supergoop, a sunscreen company that brands itself as reef-safe and free of hundreds of potentially problematic ingredients. This year, the is-sunscreen-dangerous news cycle started in May, when Valisure, ...
Source: TIME: Health - August 2, 2021 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized healthscienceclimate Public Health Source Type: news

FDA document admits "covid" PCR test was developed without isolated covid samples for test calibration, effectively admitting it's testing something else
(Natural News) A document just released by the U.S. Food and Drug Administration (FDA) openly admits that the infamous PCR test for the Wuhan coronavirus (Covid-19) was developed not with actual samples of the Chinese Virus, but rather what appears to be genetic material from a common cold virus. Since the Fauci Flu in any... (Source: NaturalNews.com)
Source: NaturalNews.com - August 1, 2021 Category: Consumer Health News Source Type: news

Uptravi (selexipag) Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)
TITUSVILLE, N.J.– July 30, 2021– The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Uptravi (selexipag) injection for intravenous (IV) use for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 30, 2021 Category: Drugs & Pharmacology Source Type: news

More child guinea pigs needed: FDA asks for more children to take part in experimental trials of deadly coronavirus vaccines
(Natural News) The Food and Drug Administration (FDA) has asked for more children to participate in Wuhan coronavirus (COVID-19) vaccine trials. It explained the trials will determine if cases of cardiac inflammation are common among younger groups. The FDA reached out to Pfizer and Moderna, whose mRNA vaccines were linked to the side effect, for... (Source: NaturalNews.com)
Source: NaturalNews.com - July 30, 2021 Category: Consumer Health News Source Type: news

Report Questions Benefit of FDA Accelerated Approval Pathway
FRIDAY, July 30, 2021 -- Many of the drugs in the U.S. Food and Drug Administration accelerated approval pathway have not been confirmed as clinically effective, despite the requirement for postapproval confirmatory trials, according to an... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 30, 2021 Category: Pharmaceuticals Source Type: news

UPTRAVI ® (selexipag) Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)
TITUSVILLE, N.J. – July 30, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved UPTRAVI® (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy. UPTRAVI® IV is a therapeutic option that will allow patients to avoid short-term treatment interruptions and stay on UPTRAVI® therapy, as uninterrupted treatment is considered key for individ...
Source: Johnson and Johnson - July 30, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

After failing to ban kratom domestically, the FDA is now pushing the UN and the WHO to ban it globally
(Natural News) The U.S. Food and Drug Administration (FDA) is on a mission to eliminate all consumer access to the herb mitragyna speciosa, also known as kratom – and your help is needed to stop it. Back in 2016, the FDA tried, and was almost successful, at getting kratom banned here in the United States.... (Source: NaturalNews.com)
Source: NaturalNews.com - July 30, 2021 Category: Consumer Health News Source Type: news

FDA Approves First Biosimilar Insulin Product
THURSDAY, July 29, 2021 -- The first interchangeable biosimilar insulin product has been approved by the U.S. Food and Drug Administration, providing patients with a cost-effective option for treating diabetes, the agency announced... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 29, 2021 Category: Pharmaceuticals Source Type: news

McCormick Recalls Seasonings Over ​Salmonella​ Risk
THURSDAY, July 29, 2021 -- McCormick& Co. on Wednesday announced the recall of several of its popular seasonings because of potential Salmonella contamination, according to the U.S. Food and Drug Administration. Included in the recall are... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 29, 2021 Category: Pharmaceuticals Source Type: news

Emergent: FDA letting troubled COVID vaccine factory restart
The U.S. Food and Drug Administration is allowing the problem-plagued factory of contract manufacturer Emergent BioSolutions to resume production of COVID-19 vaccine (Source: ABC News: Health)
Source: ABC News: Health - July 29, 2021 Category: Consumer Health News Tags: Health Source Type: news

FDA OKs Automatic Use of a Cheaper Generic   Insulin
THURSDAY, July 29, 2021 -- U.S. pharmacists will now be able to automatically substitute a cheaper biosimilar for a more expensive brand-name insulin, the U.S Food and Drug Administration announced Wednesday. The agency's approval of an... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - July 29, 2021 Category: General Medicine Source Type: news

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes
The U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. (Source: World Pharma News)
Source: World Pharma News - July 29, 2021 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

FDA accepts application for Roche ’s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Basel, 29 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the company’s submission for diabetic retinopathy.Faricimab will be the first and only bispecific antibody designed for the eye, if approved. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growt...
Source: Roche Media News - July 29, 2021 Category: Pharmaceuticals Source Type: news

FDA accepts application for Roche ’s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Basel, 29 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the company’s submission for diabetic retinopathy.Faricimab will be the first and only bispecific antibody designed for the eye, if approved. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growt...
Source: Roche Investor Update - July 29, 2021 Category: Pharmaceuticals Source Type: news

Data for Roche ’s Evrysdi® (risdiplam) published in New England Journal of Medicine shows significant improvement in survival and motor milestones in babies with Type 1 spinal muscular atrophy (SMA)
Basel, 29 July 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the New England Journal of Medicine (NEJM) has published data from FIREFISH Part 2, a pivotal global study evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies aged 1-7 months old with symptomatic Type 1 spinal muscular atr ophy (SMA). The study met its primary endpoint with 29% of infants (12/41) sitting without support for at least five seconds* by month 12, a milestone not seen in the natural course of the disease. Safety for Evrysdi in the FIREFISH Part 2 study was consistent with its known safety profile.“With...
Source: Roche Media News - July 29, 2021 Category: Pharmaceuticals Source Type: news

Data for Roche ’s Evrysdi® (risdiplam) published in New England Journal of Medicine shows significant improvement in survival and motor milestones in babies with Type 1 spinal muscular atrophy (SMA)
Basel, 29 July 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the New England Journal of Medicine (NEJM) has published data from FIREFISH Part 2, a pivotal global study evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies aged 1-7 months old with symptomatic Type 1 spinal muscular atr ophy (SMA). The study met its primary endpoint with 29% of infants (12/41) sitting without support for at least five seconds* by month 12, a milestone not seen in the natural course of the disease. Safety for Evrysdi in the FIREFISH Part 2 study was consistent with its known safety profile.“With...
Source: Roche Investor Update - July 29, 2021 Category: Pharmaceuticals Source Type: news

GSK Announces FDA Approval for Nucala (mepolizumab) for use in Adults with Chronic Rhinosinusitis with Nasal Polyps
29 July 2021 -- GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 29, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Botox (onabotulinumtoxinA) Label to Include Eight New Muscles to Treat Adults with Upper Limb Spasticity
NORTH CHICAGO, Ill., July 29, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion of Botox® to include eight new muscles for the treatment... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 29, 2021 Category: Drugs & Pharmacology Source Type: news

Alkem Laboratories says USFDA inspection at Taloja facility ends with 'zero' observations
The US Food and Drug Administration (USFDA) had conducted a remote and virtual bio-analytical inspection of the company's Bioequivalence Center located at Taloja, Maharashtra from July 26-28, 2021, Alkem Laboratories said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 29, 2021 Category: Pharmaceuticals Source Type: news

FDA Approves Semglee (insulin glargine-yfgn) as the First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
SILVER SPRING, Md., July 28, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 28, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Grants Orphan Drug Designation to Novel Mesothelioma Treatment
The U.S. Food and Drug Administration has granted orphan drug designation to ONCOFID-P for the treatment of malignant pleural mesothelioma, a step toward another potential therapy option for patients. ONCOFID-P is an innovative drug conjugate already in advanced clinical development for the treatment of invasive bladder cancer. The mesothelioma designation is based on preclinical data showing high antitumor activity in laboratory and mice models. Fidia Farmaceutici, a multinational research company based in Italy, announced the latest FDA designation, which is designed to encourage the development of novel drugs, par...
Source: Asbestos and Mesothelioma News - July 28, 2021 Category: Environmental Health Authors: Fran Mannino Source Type: news

FDA Panel Advisor Who Panned New Alzheimer's Drug Speaks Out
WEDNESDAY, July 28, 2021 -- An outside advisor to the U.S. Food and Drug Administration's review of the controversial Alzheimer's drug Aduhelm is now speaking out, arguing that the approval was based on dodgy science and involved questionable... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - July 28, 2021 Category: General Medicine Source Type: news

Biogen Defends Newly Approved Alzheimer's Drug
The US Food and Drug Administration has called for a federal investigation of its own regulatory review process after widespread criticism of its decision on Aduhelm. (Source: The Scientist)
Source: The Scientist - July 27, 2021 Category: Science Tags: News & Opinion Source Type: news

FDA Approves Keytruda (pembrolizumab) for Treatment of Patients With High-Risk Early-Stage Triple-Negative Breast Cancer in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Single Agent as Adjuvant Treatment After Surgery
KENILWORTH, N.J.--(BUSINESS WIRE) July 27, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 27, 2021 Category: Drugs & Pharmacology Source Type: news

Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem
DUBLIN, Ireland and CHICAGO, July 26, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the“Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 27, 2021 Category: Drugs & Pharmacology Source Type: news

Chemical giants hid dangers of "forever chemicals" in food packaging for more than a decade
(Natural News) Chemical giants DuPont and Daikin had known about the dangers of certain chemicals used in food packaging since 2010 but hid them from the Food and Drug Administration (FDA), The Guardian first reported. The chemicals, known as 6:2 fluorotelomer alcohol (FTOH), have been linked to several health problems, such as developmental problems, cancer and liver... (Source: NaturalNews.com)
Source: NaturalNews.com - July 26, 2021 Category: Consumer Health News Source Type: news

Public Notification: Hydro Pinapple [sic] Burn contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Hydro Pinapple [sic] Burn, a product promoted and sold for weight loss on various websites, including www.Ebay.com, and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 26, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Biden admin signals intent to force FDA approval of COVID vaccines
(Natural News) The Biden Administration has signaled its next move as part of the White House’s full court press to pressure Americans into taking COVID-19 vaccines. (Article by Jordan Schachtel republished from Dossier.Substack.com) It seems the White House intends to strongarm the Food and Drug Administration (FDA) into fully approving COVID vaccines, while completely dismissing... (Source: NaturalNews.com)
Source: NaturalNews.com - July 26, 2021 Category: Consumer Health News Source Type: news

Covid US: Pfizer and Moderna expand vaccine clinical trials in children aged 5-11
Pfizer-BioNTech and Moderna are expanding the sizes of their COVID-19 vaccine clinical trials in children ages five to 11 at the urging of the U.S. Food and Drug Administration (FDA). (Source: the Mail online | Health)
Source: the Mail online | Health - July 26, 2021 Category: Consumer Health News Source Type: news

GlaxoSmithKline begins shipping a record quantity of influenza vaccine doses for flu season
GlaxoSmithKline has started shipping what it said will be a record number of its quadrivalent influenza vaccine doses to U.S. health care providers and pharmacies for the 2021-22 flu season. GSK (NYSE: GSK) expects to distribute more than 50 million doses of its influenza vaccine for the upcoming flu season. The shipping follows a licensing and lot-release approval for the vaccine from the Food and Drug Administration's Center for Biologics Evaluation and Research. The Centers for Di sease Control… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - July 26, 2021 Category: American Health Authors: John George Source Type: news

Kids Still Dying From Accidental Exposure to Fentanyl Pain Patches
MONDAY, July 26, 2021 -- Accidental exposure to fentanyl pain patches is putting children's lives at risk, the U.S. Food and Drug Administration warns. Fentanyl is a powerful opioid pain reliever; so powerful that fentanyl patches are typically only... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - July 26, 2021 Category: General Medicine Source Type: news

Fauci Sounds Alarm Over Low Covid Vaccination Rates
With only about half of Americans vaccinated, Dr. Anthony Fauci and other current and former health officials vigorously pressed the case on Sunday that inoculations were the best way to stem a tide of new Covid cases. (Source: NYT Health)
Source: NYT Health - July 26, 2021 Category: Consumer Health News Authors: Pam Belluck Tags: Vaccination and Immunization Coronavirus (2019-nCoV) Food and Drug Administration Centers for Disease Control and Prevention Fauci, Anthony S Adams, Jerome M (1974- ) Source Type: news

Shingrix Approved in the US for Prevention of Shingles in Immunocompromised Adults
Philadelphia, London -- 26 July 2021 -- GlaxoSmithKline plc today announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 26, 2021 Category: Drugs & Pharmacology Source Type: news

CDC withdraws fraudulent PCR testing protocol that was used to falsify covid "positives" to push the plandemic
(Natural News) After more than a year of committing scientific fraud to push false “positives” via PCR testing, the CDC has announced it is withdrawing the RT-PCR Diagnostic Panel on December 31st of this year: After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use... (Source: NaturalNews.com)
Source: NaturalNews.com - July 25, 2021 Category: Consumer Health News Source Type: news

JJ vaccine may cause Guillain-Barré Syndrome, warns FDA
(Natural News) The Food and Drug Administration (FDA) states that Guillain-Barré Syndrome (GBS) is a potential adverse effect of the Johnson & Johnson COVID-19 vaccine. According to the agency, there have been 100 reports of the rare but serious neurological disorder, following vaccination with said vaccine as of July 13. GBS causes inflammation of the nerves which can lead to... (Source: NaturalNews.com)
Source: NaturalNews.com - July 25, 2021 Category: Consumer Health News Source Type: news

Biden Officials Now Expect Vulnerable Americans to Need Booster Shots
The growing consensus that at least some Americans will need a booster is partly tied to research suggesting that Pfizer ’s vaccine is less effective after about six months. (Source: NYT Health)
Source: NYT Health - July 24, 2021 Category: Consumer Health News Authors: Sharon LaFraniere Tags: Vaccination and Immunization Coronavirus (2019-nCoV) Clinical Trials Centers for Disease Control and Prevention Food and Drug Administration Pfizer Inc Moderna Inc Johnson & Offit, Paul A Source Type: news

FDA: Guidance Documents Related to Coronavirus Disease 2019; Availability
The Food and Drug Administration (FDA) has released several guidance documents related to the COVID-19 public health emergency. These guidances have been implemented without prior comment but are subject to comment per FDA policies. Includes details on how to submit comments and indicates that there is no deadline for comments. (Source: Federal Register updates via the Rural Assistance Center)
Source: Federal Register updates via the Rural Assistance Center - July 23, 2021 Category: Rural Health Source Type: news

FDA: Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
The Food and Drug Administration has issued an Emergency Use Authorization for certain medical devices related to the COVID-19 pandemic. These authorizations are effective on their date of issuance. (Source: Federal Register updates via the Rural Assistance Center)
Source: Federal Register updates via the Rural Assistance Center - July 23, 2021 Category: Rural Health Source Type: news

Dalvance (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients
NORTH CHICAGO, Ill., July 23, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved Dalvance® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 23, 2021 Category: Drugs & Pharmacology Source Type: news

Biden Says Full Approval for COVID-19 Vaccines Coming Soon
THURSDAY, July 22, 2021 -- As he urged Americans who are still hesitant to get vaccinated, President Joe Biden told an Ohio town hall on Wednesday night that he expected the U.S. Food and Drug Administration would soon give final approval to... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 22, 2021 Category: Pharmaceuticals Source Type: news

Muffins Recalled for Possible Listeria Contamination
THURSDAY, July 22, 2021 -- Possible Listeria contamination has triggered the nationwide recall of more than two dozen muffin products made by Give and Go Prepared Foods, the U.S. Food and Drug Administration said Wednesday. The recalled products... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 22, 2021 Category: Pharmaceuticals Source Type: news

Aducanumab for Alzheimer's disease: expediting approval and delaying science
At the beginning of this month of June, the Food and Drug Administration (FDA) announced its decision to grant marketing authorisation to the monoclonal antibody aducanumab, the first treatment option targeting and affecting the underlying disease process of Alzheimer's disease, according to the press release of the medicines regulatory agency of the USA. What should have been a source of joy and recognition of the success of basic and clinical sciences, however, resulted in a bitter dispute in the scientific community, that ended up in the resignation of three of the experts who had participated in the committee that advi...
Source: Current Awareness Service for Health (CASH) - July 22, 2021 Category: Consumer Health News Source Type: news

CAR T-Cell Therapy Showing Promise with Pleural Mesothelioma
Memorial Sloan Kettering Cancer Center continues its drive toward a future that may involve innovative CAR T-cell therapy as part of standard-of-care treatment for malignant pleural mesothelioma. The latest step was a clinical trial exploring a first-in-human, intrapleural-administered CAR T-cell therapy used in combination with pembrolizumab, a well-known immunotherapy drug also known by the brand name Keytruda. Results were impressive, including a 23.9-month median overall survival and an 83% one-year survival rate for patients. Cancer Discovery published the single-center study results July 15. “There is ...
Source: Asbestos and Mesothelioma News - July 22, 2021 Category: Environmental Health Authors: Chris Elkins Source Type: news