FDA Newswatch
Catalent Signs Commercial Supply Agreement with Blueprint Medicines Following FDA Approval of GAVRETO™ (pralsetinib)
23 Nov 2020 22:00:00 UT
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today...
Viatris Announces FDA Tentative Approval of a Pediatric Formulation of Dolutegravir (DTG) Under PEPFAR
23 Nov 2020 22:14:02 UT
COVID-19 antibody treatment with ties to UW Health gets FDA green light
23 Nov 2020 21:54:22 UT
MADISON, Wis. (WMTV) - A covid-19 treatment aimed at keeping those who contract the virus out of the hospital, now has the green light from the The U.S. Food and Drug Administration. The FDA gave...
Apyx Medical Gets FDA Nod To Start Mid-Stage Trial In Skin Laxity Procedures -- Stock Jumps 9% After-Hours
23 Nov 2020 12:00:00 UT
Apyx Medical (APYX), a maker of medical devices, said on Monday it has secured approval from the US Food and Drug Administration to begin a mid-stage trial of its clinical study evaluating the use of...
Neuronetics® Receives FDA Clearance for Three-Minute TouchStar„¢ Treatment Protocol; TouchStar theta burst protocol leverages NeuroStar® Advanced Therapy's patented Contact Sensing technology to help ensure the optimum prescribed treatment dose to patient
23 Nov 2020 12:00:00 UT
MALVERN, Pa., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a commercial stage medical technology company focused on designing, developing and marketing products that improve...
Apyx Medical Corporation Announces Approval from FDA to Begin Phase II of U.S. IDE Study
23 Nov 2020 12:00:00 UT
Apyx Medical Corporation (NASDAQ:APYX) (the "Company"), a maker of medical devices and supplies and the developer of Helium Plasma Technology, marketed and sold as Renuvion® in the cosmetic surgery...
Third COVID Vaccine Shows Effectiveness; FDA Grants Emergency Use Authorization for New Treatment
23 Nov 2020 13:11:00 UT
MONDAY, Nov. 23, 2020 – Americans were greeted with possible advances against coronavirus as Thanksgiving week began: A third vaccine candidate AZD1222 shows good results in shielding recipients...
Viatris Inc. Announces FDA Tentative Approval of a Pediatric Formulation of Dolutegravir (DTG) Under PEPFAR; Tentative approval will help enhance access to WHO-recommended pediatric medicine and reduce the cost of HIV treatment for children in low- and mi
23 Nov 2020 12:00:00 UT
PR Newswire  Viatris Inc. (NASDAQ: VTRS), a new kind of healthcare company, today announced tentative approval from the U.S. Food and Drug Administration (FDA) for a New Drug Application for...
Roche's Genentech Wins Expanded FDA Approval for Influenza Treatment
23 Nov 2020 12:00:00 UT
Roche's Genentech (RHHBY) said the FDA has granted expanded regulatory approval for its drug baloxavir marboxil, or Xofluza, for the prevention of influenza in people aged 12 and older who have been...
Pfizer, BioNTech to submit emergency authorization request to FDA Friday for COVID-19 vaccine
23 Nov 2020 21:21:28 UT
Feds to distribute 30K doses of new Regeneron COVID-19 antibody cocktail just approved by FDA
23 Nov 2020 20:19:00 UT
The Trump administration announced plans to distribute on Tuesday 30,000 doses of a newly approved antibody cocktail designed to fight mild and moderate cases of COVID-19. Administration officials...
Trump White House still sitting on FDA CBD guidance
23 Nov 2020 19:47:00 UT
A CBD guidance pending before the White House’s Office of Management and Budget (OMB) will likely not be published during the waning days of the Trump administration, several industry sources...
FDA issues EUA for new COVID-19 treatment
23 Nov 2020 19:15:15 UT
On Saturday, FDA issued an emergency use authorization (EUA) for a combination monoclonal antibody treatment—casirivimab and imdevimab (Regeneron Pharmaceuticals)—to be administered together for the...
FDA OKs baloxavir marboxil as postexposure prophylaxis for flu
23 Nov 2020 20:45:16 UT
1 min read ADD TOPIC TO EMAIL ALERTS Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted...
FDA Approves First Drug For A Rapid Aging Disorder In Children
23 Nov 2020 15:52:00 UT
The FDA has approved a drug that extends the lives of children with progeria, an extremely rare genetic disorder that causes rapid aging. The FDA has approved a drug that extends the lives of...
AliveCore gets FDA nod for suite of cardiac focused AI algorithms
23 Nov 2020 19:25:30 UT
The new algorithms will be able to detect for sinus rhythm with premature ventricular contractions, supraventricular ectopy and sinus rhythm with wide QRS. Cardio-focused digital health company...
Catalent Signs Commercial Supply Agreement with Blueprint Medicines Following FDA Approval of GAVRETO (pralsetinib)
23 Nov 2020 20:51:32 UT
Neurelis Completes Pre-IND Meeting With FDA to Establish Clinical Development Program for NRL-4 in the Treatment of Acute Agitation Associated With Schizophrenia and Bipolar 1 Mania in Adults
23 Nov 2020 20:51:32 UT
Regeneron’s COVID-19 cocktail gets FDA emergency use authorization
23 Nov 2020 06:00:00 UT
Get great content like this right in your inbox. The Food and Drug Administration has granted emergency use authorization for Regeneron Pharmaceuticals’ antibody cocktail casirivimab and imdevimab...
FDA Authorizes Regeneron’s Monoclonal Antibody Treatment for COVID-19
23 Nov 2020 08:05:08 UT
The US FDA issued an emergency use authorization (EUA) for Regeneron’s casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric...