Feb 11 More data needed on Pfizer’s COVID-19 vaccine for kids under 5, FDA says By Lauran Neergaard, Matthew Perrone, Associated Press The Food and Drug Administration had urged Pfizer and its partner BioNTech to apply for authorization of extra-low doses of its vaccine for the youngest children before clinical studies were finished. On Friday, the FDA reversed course. Continue reading
Dec 16 U.S. regulators say abortion pill no longer has to be picked up in person By Matthew Perrone, Associated Press Earlier this year the FDA stopped enforcing the in-person dispending requirement because of the pandemic. Under Thursday's decision the agency will permanently drop the rule. Continue reading
Dec 14 WATCH: Senate hearing on the nomination of Robert Califf as commissioner of FDA By Ricardo Alonso-Zaldivar, Matthew Perrone, Associated Press President Joe Biden’s pick to lead the Food and Drug Administration deftly parried questions on crises ranging from the COVID pandemic to the opioid epidemic. Continue reading
Nov 12 Biden picks former FDA chief Califf to again lead the agency By Matthew Perrone, Zeke Miller, Associated Press Califf served as FDA commissioner for the last 11 months of President Barack Obama’s second term. Continue reading
Oct 15 FDA panel endorses booster shot for Johnson & Johnson COVID-19 vaccine By Matthew Perrone, Lauran Neergaard, Associated Press J&J has asked the Food and Drug Administration for flexibility with its booster, arguing the extra dose adds important protection as early as two months after initial vaccination -- but that it might work better if people wait until six… Continue reading
Oct 14 WATCH: FDA advisory committee debates Johnson & Johnson COVID-19 booster shots By Matthew Perrone, Lauran Neergaard, Associated Press The FDA’s Vaccines and Related Biological Products Advisory Committee is expected to hold a meeting on Friday to discuss the emergency authorization of booster doses of the Johnson & Johnson COVID-19 vaccine for people 18 and older. Continue reading
Oct 14 FDA panel endorses lower-dose Moderna COVID shot for booster By Lauran Neergaard, Matthew Perrone, Associated Press U.S. health advisors said Thursday that some Americans who received Moderna’s COVID-19 vaccine should get a half-dose booster to bolster protection against the virus. Continue reading
Oct 13 FDA spells out lower sodium goals for food industry By Candice Choi, Associated Press U.S. regulators on Wednesday spelled out long-awaited guidelines aimed at reducing sodium levels in dozens of foods including condiments, french fries and potato chips. Continue reading
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