Sep 30 U.S. stem cell clinics boomed while FDA paused crackdown By Matthew Perrone, Associated Press The Food and Drug Administration gave clinics three years to show that their questionable treatments were safe and worked. But today none of the clinics have won FDA approval and there are more businesses than before selling the treatments for… Continue reading
Sep 22 FDA backs Pfizer COVID-19 boosters for seniors, high-risk By Matthew Perrone, Lauran Neergaard, Mike Stobbe, Associated Press The FDA on Wednesday signed off on such shots as a way to shore up protection in those groups. This is not a done deal yet: The CDC has yet to weigh in on who it believes should get boosters… Continue reading
Sep 17 FDA advisory panel rejects widespread Pfizer vaccine booster shots By Matthew Perrone, Lauren Neergaard, Associated Press An influential federal advisory panel has overwhelmingly rejected a plan to give Pfizer booster shots against COVID-19 to most Americans, but it approved the extra doses for those who are 65 or older or run a high risk of severe… Continue reading
Sep 16 WATCH: FDA panel shows frustration in booster dose debate By Lauran Neergaard, Matthew Perrone, Associated Press, Associated Press An influential federal advisory panel has overwhelmingly rejected a plan to give Pfizer booster shots against COVID-19 to most Americans, but it endorsed the extra shots for those who are 65 or older or run a high risk of severe… Continue reading
Sep 13 FDA experts among group opposing U.S. booster shot plan By Lauran Neergaard, Matthew Perrone, Associated Press An international group of scientists is arguing the average person doesn't need a COVID-19 booster yet — an opinion that highlights the intense scientific divide over the question. Continue reading
Sep 10 AP report: FDA official hopeful younger kids can get shots this year By Lauren Neergaard, Associated Press Dr. Peter Marks tells The Associated Press he is "very, very hopeful" that vaccinations for 5- to 11-year-olds will be underway by year's end. One company, Pfizer, is expected to turn over its study results by the end of September. Continue reading
Sep 09 FDA delays decision on e-cigarette ban for vaping giant Juul By Matthew Perrone, Associated Press Parents, politicians and anti-tobacco advocates have pressured the FDA for years to ban Juul's high-nicotine devices, which many blame for the recent spike in underage vaping. Continue reading
Jul 28 FDA allows automatic ‘generic’ swap for brand-name insulin By Linda A. Johnson, Associated Press Wednesday's move by the Food and Drug Administration will allow pharmacists to automatically substitute the cheaper version, just as they do with generic pills for other kinds of drugs. Continue reading
Jul 09 FDA head calls for probe into Alzheimer’s drug review By Matthew Perrone, Associated Press Dr. Janet Woodcock announced the extraordinary step via Twitter. It's the latest fallout over last month's approval of Aduhelm, an expensive and unproven therapy that the agency OK'd against the advice of its own outside experts. Continue reading
Jul 08 Pfizer to seek approval for 3rd vaccine dose, says it could ward off delta variant By Lauran Neergaard, Associated Press The company said Thursday that another shot could dramatically boost immunity and maybe help ward off the latest worrisome coronavirus mutant. Continue reading