Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV
TITUSVILLE, N.J., January 21, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s 25-year commitment to make HIV history. In the U.S., ViiV Healthcare is the marketing authorization holde...
Source: Johnson and Johnson - January 22, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

F.D.A. Approves Monthly Shots to Treat H.I.V.
A combination of two injectable drugs will provide an alternative to daily pills for people with H.I.V. (Source: NYT Health)
Source: NYT Health - January 22, 2021 Category: Consumer Health News Authors: Apoorva Mandavilli Tags: your-feed-science Acquired Immune Deficiency Syndrome Drugs (Pharmaceuticals) Food and Drug Administration United States Source Type: news

Rhizen receives USFDA orphan drug designation for cancer drug
The US Food and Drug Administration (USFDA) has granted orphan drug designation for Tenalisib (RP6530) for the treatment of patients with peripheral T-cell lymphoma (PTCL), Alembic Pharmaceuticals said in a BSE filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 22, 2021 Category: Pharmaceuticals Source Type: news

Hahn Resigns as Head of FDA, Dr. Janet Woodcock New Interim Chief
THURSDAY, Jan. 21, 2021 -- Stephen Hahn, M.D., resigned as commissioner of the U.S. Food and Drug Administration on Wednesday. Hahn became head of the agency just weeks before the start of the COVID-19 pandemic and was widely criticized during the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 21, 2021 Category: Pharmaceuticals Source Type: news

Moderna coronavirus vaccine causes dermal filler reactions, warns FDA
(Natural News) Last December 2020, health experts from the Food and Drug Administration (FDA) warned that Moderna’s coronavirus (COVID-19) vaccine has yet another negative side effect: Upon vaccination, people with cosmetic facial fillers experienced “swelling and inflammation.” Most of the recipients of Moderna’s coronavirus vaccine have experienced mild side effects like headache, fatigue and pain at the injection site. Vaccine recipients... (Source: NaturalNews.com)
Source: NaturalNews.com - January 21, 2021 Category: Consumer Health News Source Type: news

With Little Data to Guide Them, Pregnant Health Care Workers Are Stepping Up to Get Vaccinated Against COVID-19
Dr. Jacqueline Parchem, a maternal-fetal medicine physician at UTHealth in Houston, considers herself a private person. Even still, she logged on to Twitter on Dec. 22 and began drafting a series of posts. “Pregnant and unsure about the #COVID19 vaccine?” she wrote in a tweet that has now been liked more than 3,000 times. “You’re not alone. Got vaccinated today at 31 weeks [pregnant] and feel very fortunate. But it’s complicated.” Over the course of nine tweets, Parchem broke down the thinking that went into her difficult decision to get vaccinated during pregnancy. Ultimately, she wrote...
Source: TIME: Health - January 21, 2021 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized COVID-19 Source Type: news

FDA grants priority review to Roche ’s Esbriet (pirfenidone) for unclassifiable interstitial lung disease
Basel, 21 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). The FDA is expected to make a decision on approval by May 2021.“Since its US approval, Esbriet has become a standard of care for people living with idiopathic pulmonary fibrosis. However, significant unmet need remains in fibrotic lung diseases, including unclassifiable interstitial lung disease ...
Source: Roche Investor Update - January 21, 2021 Category: Pharmaceuticals Source Type: news

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction
KENILWORTH, N.J.--(BUSINESS WIRE)-- 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 Verquvo, a soluble guanylate cyclase (sGC) stimulator, to reduce... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 20, 2021 Category: Drugs & Pharmacology Source Type: news

Hahn Resigns as F.D.A. Commissioner; Woodcock Named Interim Chief
The Biden administration has yet to name a permanent chief of the Food and Drug Administration, amid a deep review of potential treatments and vaccines against the coronavirus. (Source: NYT Health)
Source: NYT Health - January 20, 2021 Category: Consumer Health News Authors: Sheila Kaplan Tags: Appointments and Executive Changes Coronavirus (2019-nCoV) United States Politics and Government Vaccination and Immunization Food and Drug Administration Biden, Joseph R Jr Hahn, Stephen M (1960- ) Trump, Donald J your-feed-healthcare Source Type: news

FDA commissioner Hahn leaves agency
Dr. Stephen Hahn, the commissioner of the U.S. Food and Drug Administration...Read more on AuntMinnie.comRelated Reading: FDA proposal to relax 510(k) rules on AI raises eyebrows FDA publishes action plan for medical AI software FDA makes history with approval of Ga-68 PSMA-11 PET Topol blasts FDA chief Hahn on blood plasma approval Senate confirms Hahn as FDA commissioner (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 20, 2021 Category: Radiology Source Type: news

FDA clears use of MRI for Impulse Dynamics' Optimizer
The U.S. Food and Drug Administration (FDA) has cleared for conditional use...Read more on AuntMinnie.comRelated Reading: Socioeconomic status predicts heart failure mortality AI predicts heart attack, stroke on cardiac MRI MRI discovers heart damage among male triathletes (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 20, 2021 Category: Radiology Source Type: news

Public Notification: Adam ’s Secret Extra Strength 3000 Platinum contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Adam ’s Secret Extra Strength 3000 Platinum, a product promoted and sold for sexual enhancement on various websites, including www.adamssecret.co, 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 - January 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Adam ’s Secret Extra Strength 1500 contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Adam ’s Secret Extra Strength 1500, a product promoted and sold for sexual enhancement on various websites, including www.adamssecret.co and www.walmart.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 - January 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

DePuy Synthes Receives 510(k) FDA Clearance for VELYS ™ Robotic-Assisted Solution Designed for Use with the ATTUNE® Total Knee System
PALM BEACH GARDENS, FL., January 19, 2021 – Today, The Johnson & Johnson Medical Devices Companies* announced that DePuy Synthes** has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VELYS™ Robotic-Assisted Solution designed for use with the ATTUNE® Total Knee System and its cleared indications for use. It will become part of the broader VELYS Digital Surgery Platform of connected technologies. With a growing and aging patient population, demand for joint replacement surgery is increasing. But across the industry, data shows up to 20% of knee replacement patients aren&...
Source: Johnson and Johnson - January 19, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Occlutech's Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation for Heart Failure (HF)
SCHAFFHAUSEN, Switzerland, Jan. 19, 2021 -- (Healthcare Sales & Marketing Network) -- Occlutech, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the Company a Breakthrough Device designation for its fi... Devices, Cardiology, FDA Occlutech, Atrial Flow Regulator, heart failure (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 19, 2021 Category: Pharmaceuticals Source Type: news

FDA proposal to relax 510(k) rules on AI raises eyebrows
A proposal by the U.S. Food and Drug Administration (FDA) to eliminate 510(k)...Read more on AuntMinnie.comRelated Reading: FDA publishes action plan for medical AI software Feedback on FDA's proposed AI rules had industry ties FDA relaxes rules on imaging modifications for COVID-19 FDA recognizes AI-based image acquisition software FDA eyes new framework for AI that continuously learns (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 19, 2021 Category: Radiology Source Type: news

FDA: Authorizations of Emergency Use of Two Biological Products During the COVID-19 Pandemic; Availability
Notice from the Food and Drug Administration (FDA) announcing the issuance of Emergency Use Authorizations for biological products for use during the COVID-19 pandemic, one for Pfizer, Inc. and another for ModernaTX, Inc. 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 - January 19, 2021 Category: Rural Health Source Type: news

191 San Diego Fire-Rescue Personnel Decline COVID-19 Vaccine So Far
David Hernandez The San Diego Union-Tribune (TNS) Nearly 200 San Diego Fire-Rescue personnel have so far turned down a COVID-19 vaccine, showing reluctance as health officials scramble to protect frontline workers like firefighters from the highly infectious coronavirus. As of Wednesday, 191 personnel had declined to take the vaccine; 895 had gotten the shot, according to department figures. The vaccine is available to all of the department’s roughly 1,500 employees, including lifeguards and non-sworn staff, a spokeswoman said. The force includes 943 firefighters, who double as paramedics or emergency ...
Source: JEMS Patient Care - January 18, 2021 Category: Emergency Medicine Authors: JEMS Staff Tags: Coronavirus Industry News California San Diego Source Type: news

191 San Diego Fire-Rescue Personnel Decline COVID-19 Vaccine So Far
David Hernandez The San Diego Union-Tribune (TNS) Nearly 200 San Diego Fire-Rescue personnel have so far turned down a COVID-19 vaccine, showing reluctance as health officials scramble to protect frontline workers like firefighters from the highly infectious coronavirus. As of Wednesday, 191 personnel had declined to take the vaccine; 895 had gotten the shot, according to department figures. The vaccine is available to all of the department’s roughly 1,500 employees, including lifeguards and non-sworn staff, a spokeswoman said. The force includes 943 firefighters, who double as paramedics or emergency ...
Source: JEMS Administration and Leadership - January 18, 2021 Category: Emergency Medicine Authors: JEMS Staff Tags: Coronavirus Industry News California San Diego Source Type: news

191 San Diego Fire-Rescue Personnel Decline COVID-19 Vaccine So Far
David Hernandez The San Diego Union-Tribune (TNS) Nearly 200 San Diego Fire-Rescue personnel have so far turned down a COVID-19 vaccine, showing reluctance as health officials scramble to protect frontline workers like firefighters from the highly infectious coronavirus. As of Wednesday, 191 personnel had declined to take the vaccine; 895 had gotten the shot, according to department figures. The vaccine is available to all of the department’s roughly 1,500 employees, including lifeguards and non-sworn staff, a spokeswoman said. The force includes 943 firefighters, who double as paramedics or emergency ...
Source: JEMS Latest News - January 18, 2021 Category: Emergency Medicine Authors: JEMS Staff Tags: Coronavirus Industry News California San Diego Source Type: news

191 San Diego Fire-Rescue Personnel Decline COVID-19 Vaccine So Far
David Hernandez The San Diego Union-Tribune (TNS) Nearly 200 San Diego Fire-Rescue personnel have so far turned down a COVID-19 vaccine, showing reluctance as health officials scramble to protect frontline workers like firefighters from the highly infectious coronavirus. As of Wednesday, 191 personnel had declined to take the vaccine; 895 had gotten the shot, according to department figures. The vaccine is available to all of the department’s roughly 1,500 employees, including lifeguards and non-sworn staff, a spokeswoman said. The force includes 943 firefighters, who double as paramedics or emergency ...
Source: JEMS: Journal of Emergency Medical Services News - January 18, 2021 Category: Emergency Medicine Authors: JEMS Staff Tags: Coronavirus Industry News California San Diego Source Type: news

191 San Diego Fire-Rescue Personnel Decline COVID-19 Vaccine So Far
David Hernandez The San Diego Union-Tribune (TNS) Nearly 200 San Diego Fire-Rescue personnel have so far turned down a COVID-19 vaccine, showing reluctance as health officials scramble to protect frontline workers like firefighters from the highly infectious coronavirus. As of Wednesday, 191 personnel had declined to take the vaccine; 895 had gotten the shot, according to department figures. The vaccine is available to all of the department’s roughly 1,500 employees, including lifeguards and non-sworn staff, a spokeswoman said. The force includes 943 firefighters, who double as paramedics or emergency ...
Source: JEMS Operations - January 18, 2021 Category: Emergency Medicine Authors: JEMS Staff Tags: Coronavirus Industry News California San Diego Source Type: news

191 San Diego Fire-Rescue Personnel Decline COVID-19 Vaccine So Far
David Hernandez The San Diego Union-Tribune (TNS) Nearly 200 San Diego Fire-Rescue personnel have so far turned down a COVID-19 vaccine, showing reluctance as health officials scramble to protect frontline workers like firefighters from the highly infectious coronavirus. As of Wednesday, 191 personnel had declined to take the vaccine; 895 had gotten the shot, according to department figures. The vaccine is available to all of the department’s roughly 1,500 employees, including lifeguards and non-sworn staff, a spokeswoman said. The force includes 943 firefighters, who double as paramedics or emergency ...
Source: JEMS Special Topics - January 18, 2021 Category: Emergency Medicine Authors: JEMS Staff Tags: Coronavirus Industry News California San Diego Source Type: news

Ascend Laboratories recalls over 20,000 bottles of antibacterial drug in US
The US-based Ascend Laboratories LLC is recalling 20,232 bottles of Cephalexin for oral suspension, USP, 125 mg per 5 mL, manufactured by Alkem Laboratories, according to the latest Enforcement Report by the US Food and Drug Administration. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 17, 2021 Category: Pharmaceuticals Source Type: news

Last-Minute Rule Seeks Term Limits on Top Career Health Officials
The Trump administration wants to mandate job reviews for top government scientists and managers every five years, which could lead to reassignment. (Source: NYT)
Source: NYT - January 16, 2021 Category: American Health Authors: Noah Weiland and Margot Sanger-Katz Tags: Health and Human Services Department Law and Legislation Term Limits (Political Office) Trump, Donald J Food and Drug Administration Source Type: news

DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which leads to th...
Source: Johnson and Johnson - January 16, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
January 15, 2021 (HORSHAM, Pa.)– The Janssen Pharmaceutical Companies of Johnson& Johnson announced today the U.S. Food and Drug Administration (FDA) approval of Darzalex Faspro® (daratumumab and hyaluronidase-fihj), a subcutaneous... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 15, 2021 Category: Drugs & Pharmacology Source Type: news

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas
On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Biden Picks Former F.D.A. Chief Kessler to Lead U.S. Vaccine Efforts
Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official at Operation Warp Speed. (Source: NYT Health)
Source: NYT Health - January 15, 2021 Category: Consumer Health News Authors: Sheila Kaplan Tags: Kessler, David A Biden, Joseph R Jr Coronavirus (2019-nCoV) Appointments and Executive Changes Vaccination and Immunization Drugs (Pharmaceuticals) Presidential Transition (US) Food and Drug Administration Content Type: Personal Profile Source Type: news

Nigeria: Fake Covid-19 Vaccines in Circulation, NAFDAC Warns
[Vanguard] The National Agency for Food and Drug Administration and Control, NAFDAC, on Friday alerted of circulation of fake vaccines in Nigeria even as it disclosed that It has not approved any vaccines or receive any application from Covid Vaccine manufacturers yet. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - January 15, 2021 Category: African Health Source Type: news

Nigeria: NAFDAC Raises the Alarm Over Fake Covid-19 Vaccine in Nigeria
[This Day] The National Agency for Food and Drug Administration and Control (NAFDAC) said it had received reports of the importation of fake vaccine into Nigeria. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - January 15, 2021 Category: African Health Source Type: news

Opioid exposure associated with poppy consumption reported to poison control centers and the U.S. Food and Drug Administration - Greenthal E, Lurie P, Doyon S.
OBJECTIVE: To assess characteristics of exposures to contaminated poppy and identify trends in exposure and poppy-related deaths. METHODS: Cross-sectional analysis of adverse events associated with exposure to poppy products (primarily poppy seeds... (Source: SafetyLit)
Source: SafetyLit - January 15, 2021 Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news

UCLA shares COVID-19 vaccine information with faculty and staff
 With two COVID-19 vaccines — one from Pfizer–BioNTech and the other from Moderna — having been approved for use by the U.S. Food and Drug Administration, vaccinations have begun across the United States, including at UCLA Health facilities, where the first doses were administered on Dec. 16, 2020. To date, more than 18, 000 UCLA Health personnel have received the vaccine, and thousands are being vaccinated each week.On Jan. 14, members of UCLA ’s COVID-19 Response and Recovery Task Force held a virtual town hall to update faculty and staff on the progress of UCLA Health’s vaccination pro...
Source: UCLA Newsroom: Health Sciences - January 15, 2021 Category: Universities & Medical Training Source Type: news

Pfizer ’s Xalkori (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults
NEW YORK--(BUSINESS WIRE) January 14, 2021 -- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Xalkori® (crizotinib) for the treatment of pediatric... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 14, 2021 Category: Drugs & Pharmacology Source Type: news

C-Path announces SHIP-MD 2021 Virtual Workshop
(Critical Path Institute (C-Path)) C-Path in collaboration with the US Food and Drug Administration's Center for Devices and Radiological Health AdvaMed, the American Academy of Pediatrics and multiple pediatric health system leaders, is proud to announce the System of Hospitals for Innovation in Pediatrics - Medical Devices Virtual Workshop to be held on February 9-11, 2021. The workshop will focus on the acceleration of medical device development for the unique needs of children. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 14, 2021 Category: International Medicine & Public Health Source Type: news

Johnson & Johnson COVID-19 Vaccine Candidate Interim Phase 1/2a Data Published in New England Journal of Medicine
January 13, 2021 -- Interim Phase 1/2a data were published today in the New England Journal of Medicine demonstrating that the Company’s single-dose investigational COVID-19 vaccine candidate (JNJ-78436735) – being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson – provided an immune response that lasted for at least 71 days, the duration of time measured in this study in participants aged 18-55 years. A preview of part of these interim data was posted on medRxiv in September 2020.The Phase 1/2a interim analysis showed that the Company’s COVID-19 vaccine candidate induced a...
Source: Johnson and Johnson - January 13, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

FDA gives nod to Siemens' Cios Flow C-arm
The U.S. Food and Drug Administration (FDA) has cleared the Cios Flow mobile...Read more on AuntMinnie.comRelated Reading: Health Canada approves Siemens angio systems New x-ray systems mark Siemens exhibit at RSNA 2020 Siemens signs 10-year deal in Iowa Siemens receives FDA clearance for Ysio X.pree Siemens adds Imbio AI apps to syngo.via platform (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 13, 2021 Category: Radiology Source Type: news

FDA expands Sportmix pet food recall after 70 dogs reportedly died
The Food and Drug Administration has expanded a recall and is alerting pet owners and veterinary professionals about high levels of... (Source: Reuters: Health)
Source: Reuters: Health - January 13, 2021 Category: Consumer Health News Source Type: news

Unichem Labs gets American drug regulator's nod to market generic Celecoxib capsules
The company has received abbreviated new drug application (ANDA) approval for its Celecoxib capsules in the strengths of 50 mg, 100 mg, 200 mg, and 400 mg from the United States Food and Drug Administration (USFDA), Unichem said in a filing to BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 13, 2021 Category: Pharmaceuticals Source Type: news

Granules gets American drug regulator's nod for diabetes management drug Metformin
The US Food and Drug Administration (USFDA) has granted final approval for the company's abbreviated new drug application (ANDA) for Metformin Hydrochloride extended-release tablets USP, 500 mg and 1000 mg, Granules said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 13, 2021 Category: Pharmaceuticals Source Type: news

FDA expands Sportmix dog food recall after 70 dogs reportedly died
The Food and Drug Administration has expanded a recall and is alerting pet owners and veterinary professionals about high levels of... (Source: Reuters: Health)
Source: Reuters: Health - January 12, 2021 Category: Consumer Health News Source Type: news

FDA publishes action plan for medical AI software
The U.S. Food and Drug Administration (FDA) has published an action plan for...Read more on AuntMinnie.comRelated Reading: Feedback on FDA's proposed AI rules had industry ties FDA recognizes AI-based image acquisition software Caption Health gets FDA nod for echo AI software FDA eyes new framework for AI that continuously learns (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 12, 2021 Category: Radiology Source Type: news

Ultromics' AI software gets thumbs-up from regulators
The U.S. Food and Drug Administration has cleared EchoGo Pro, an artificial...Read more on AuntMinnie.comRelated Reading: Ultromics, Mayo Clinic partner again in echo AI Laurel Bridge, Ultromics announce partnership Ultromics raises $10M in financing Ultromics partners with Mayo Clinic Ultromics gets FDA clearance for AI for echo (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 12, 2021 Category: Radiology Source Type: news

Helius stock makes gains after company responds to FDA questions about device application
Helius Medical Technology, a Bucks County medical device company, said Monday it has submitted its formal response to questions raised about its lead product by the Food and Drug Administration. Shares of the Newtown company's stock were trading up more than 8% at $15.54 per share in early afternoon trading. The FDA in October requested additional information about Helius' Portable Neuromodulation Stimulator, or PoNS, device which is developed initially to help patients who have walking difficulties… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - January 11, 2021 Category: Pharmaceuticals Authors: John George Source Type: news

mRNA Technology Gave Us the First COVID-19 Vaccines. It Could Also Upend the Drug Industry
“No!” The doctor snapped. “Look at me!” I had been staring her in the eyes, as she had ordered, but when a doctor on my other side began jabbing me with a needle, I started to turn my head. “Don’t look at it,” the first doctor said. I obeyed. This was in early August in New Orleans, where I had signed up to be a participant in the clinical trial for the Pfizer-BioNTech COVID-19 vaccine. It was a blind study, which meant I was not supposed to know whether I had gotten the placebo or the real vaccine. I asked the doctor if I would really been able to tell by looking at the syringe. &...
Source: TIME: Health - January 11, 2021 Category: Consumer Health News Authors: Walter Isaacson Tags: Uncategorized COVID-19 feature Magazine Source Type: news

mRNA Technology Gave Us the First COVID-19 Vaccines. It Could Also Upend the Drug Industry
“No!” The doctor snapped. “Look at me!” I had been staring her in the eyes, as she had ordered, but when a doctor on my other side began jabbing me with a needle, I started to turn my head. “Don’t look at it,” the first doctor said. I obeyed. This was in early August in New Orleans, where I had signed up to be a participant in the clinical trial for the Pfizer-BioNTech COVID-19 vaccine. It was a blind study, which meant I was not supposed to know whether I had gotten the placebo or the real vaccine. I asked the doctor if I would really been able to tell by looking at the syringe. &...
Source: TIME: Science - January 11, 2021 Category: Science Authors: Walter Isaacson Tags: Uncategorized COVID-19 feature Magazine Source Type: news

Dr Reddy's launches generic drug in the US market
The company has launched the product, which is a generic version of Teijin Ltd's Uloric tablets, after getting approval from the US Food and Drug Administration (USFDA), the company said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 11, 2021 Category: Pharmaceuticals Source Type: news

Biden and Fauci will "save" America from covid-19 as FDA prepares to fix PCR tests, eliminating millions of false positive cases by end of 2021
(Natural News) In the beginning of the “pandemic,” the Food and Drug Administration (FDA) approved fraudulent, high-cycle threshold PCR test kits that produced a high percentage of false positives — up to 97 percent. As more false positives turned up, Americans were told that they could be perfectly well, yet be “asymptomatic carriers” who also transmit infections.... (Source: NaturalNews.com)
Source: NaturalNews.com - January 10, 2021 Category: Consumer Health News Source Type: news

Los Angeles' Covid test could be issuing false negatives, FDA says
The city of Los Angeles has mounted one of the most aggressive testing strategies during the coronavirus crisis, including setting up a massive drive-through testing site at Dodger Stadium and testing asymptomatic people. But the Covid-19 test that the city has been using from a year-old Los Angeles company has come under scrutiny this week after an alert from the Food and Drug Administration (FDA). The FDA on Monday alerted patients and health care providers that the Curative SARS-Cov-2 test could… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - January 8, 2021 Category: Health Management Authors: Annlee Ellingson Source Type: news

Los Angeles' Covid test could be issuing false negatives, FDA says
The city of Los Angeles has mounted one of the most aggressive testing strategies during the coronavirus crisis, including setting up a massive drive-through testing site at Dodger Stadium and testing asymptomatic people. But the Covid-19 test that the city has been using from a year-old Los Angeles company has come under scrutiny this week after an alert from the Food and Drug Administration (FDA). The FDA on Monday alerted patients and health care providers that the Curative SARS-Cov-2 test could… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - January 8, 2021 Category: Biotechnology Authors: Annlee Ellingson Source Type: news