May 30 Hepatitis outbreak in U.S. and Canada linked to strawberries By Dee-Ann Durbin, Associated Press The strawberries were purchased between March 5 and April 25 at various U.S. retailers, including Aldi, Kroger and Walmart and at Co-op stores in Canada. Continue reading
Apr 14 FDA authorizes 1st breathalyzer test for COVID-19 By Associated Press The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said Thursday, and can be used in doctor's offices, hospitals and mobile testing sites. Continue reading
Apr 11 Can cancer blood tests live up to promise of saving lives? By Carla K. Johnson, Associated Press It’s an open question whether such cancer blood tests — if added to routine care — could improve Americans’ health or help meet the White House’s goal of cutting the cancer death rate in half over the next 25 years. Continue reading
Mar 30 FDA panel narrowly rejects experimental ALS drug By Matthew Perrone, Associated Press Wednesday's vote by the Food and Drug Administration expert panel is a potential setback for patient groups who have lobbied for the medication's approval for ALS for more than a year. Continue reading
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