Tag Archives: FDA

Shares of both Geron (GERN) and Madrigal Pharmaceuticals (MDGL) are soaring after receiving positive news from the Food and Drug Administration. For Geron, an FDA advisory panel backed its blood disorder treatment. For Madrigal, the FDA approved its treatment for a liver disease known as nonalcoholic steatohepatitis, or NASH. Yahoo Finance’s Josh Lipton and Julie Hyman discuss the stocks’ reaction in the video above. For more expert insight and the latest market action, click here to watch this… Source link

On the same day that the Centers for Disease Control and Prevention eased COVID-19 guidelines, the Food and Drug Administration issued a statement warning that at-home rapid antigen tests can deliver false negative results and people who need tests should should plan to do so more than once to make sure they are not “unknowingly spreading the SARS-CoV-2 virus to others.” Health experts recommend tests for people who have been exposed to the virus or are experiencing symptoms. “Today’s… Source link

The White House announced a plan to distribute COVID-19 vaccines for younger children — once authorized — ahead of next week’s FDA advisory meeting. The plan follows a similar strategy as those for adult and older kids’ vaccinations, including making doses available at pharmacies, hospitals, doctors offices and health clinics. “The Administration’s vaccination program for America’s youngest children will focus on addressing the specific needs of this age group and their… Source link

The FDA’s vaccine advisory committee voted in favor of Novavax’s (NVAX) COVID-19 vaccine for use in adults, paving the way for the company to get its first product authorized in the U.S. But the day-long meeting raised a number of concerns presented by Novavax’s late entry to the vaccine field. Before any data was even presented, questions were raised by committee members about the need to authorize yet another COVID-19 vaccine, as demand has waned in the U.S., and about the manufacturing… Source link

Novavax (NVAX) is finally ready to submit its application for emergency use authorization (EUA) in the U.S., and could do so as early as this week, according to CEO Stanley Erck. “We will be filing within the next few days in the U.S.,” Erck told Yahoo Finance Live on Tuesday. The company has made significant progress on its path to its first commercial product, the two-dose COVID-19 vaccine, marking three major milestones in the past week. Novavax has now received four emergency use approvals,… Source link

President Biden has selected Robert Califf as his pick for the next head of the Food and Drug Administration, the White House announced today. Califf is currently a senior advisor for Verily Life Sciences and Google Health, two divisions of parent company Alphabet. He was brought on in 2019 to lead health strategy and policy for the groups. Califf, a cardiologist, previously served as the FDA commissioner during the last year of the Obama administration. He also founded the Duke Clinical… Source link

The FDA rejected Pfizer (PFE)/BioNTech’s (BNTX) booster shot recommendation for the general public in order to place greater focus on inoculating the unvaccinated populations and collecting more data on booster shots, Meghan FitzGerald, adjunct associate professor of health policy and management at Columbia University, told Yahoo Finance Live. Though the FDA rejected the booster for the general public by a large margin (16-2), the shot was endorsed unanimously for the elderly and… Source link

A U.S. Food and Drug Administration (FDA) advisory panel voted Friday against approval of Pfizer (PFE)/BioNTech’s (BNTX) third dose for the U.S. The vote comes after a heated debate in recent weeks over the need for booster or additional shots, which both mRNA companies — Pfizer and Moderna (MRNA) — have advocated for. Dr. Peter Marks, the FDA’s leading expert on vaccines, touched on the controversy in his introductory remarks. “We know that there may be differing opinions of the… Source link

 WASHINGTON, Aug 3 (Reuters) – The U.S. Food and Drug Administration is aiming to give full approval for the Pfizer COVID vaccine by early September, the New York Times reported on Tuesday, citing people involved in the effort.    The FDA gave emergency use authorization to the Pfizer vaccine late last year. Full approval by the FDA could push more Americans to get the COVID-19 vaccine as it might reduce their fears about the safety of the shot.    The agency’s unofficial deadline for… Source link

Biotech stocks rebounded in the week ended July 23, thanks to the broader market strength. The sector also benefitted from the optimism that was set in motion by the solid start to the pharma reporting season. Big pharma companies, including Johnson & Johnson (NYSE: JNJ) and Novartis AG (NYSE: NVS) reported forecast-beating results and issued positive guidance. Preannouncements from the space were also largely positive. Moderna, Inc.’s (NASDAQ: MRNA) buoyancy spilled over into the week. The … Source link