Oct 22 U.S. regulators, experts take up thorny vaccine study issues By Lauran Neergaard, Matthew Perrone, Associated Press With vaccines against COVID-19 inching closer, U.S. regulators took an unusual step Thursday in asking outside scientists: Are the government's standards high enough to adequately judge the shots?… Continue reading
Oct 22 WATCH: FDA advisory committee assesses COVID-19 vaccine development By Helen Branswell, STAT This week's meeting, while likely dry and technical, "shows the public that this is how FDA is going about its decisions," one expert said. Continue reading
Oct 06 FDA discloses vaccine guidelines previously blocked by White House By Zeke Miller, Matthew Perrone, Associated Press In briefing documents posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out safety issues before seeking emergency approval. Continue reading
Sep 23 U.S. health officials say they would get FDA-approved COVID-19 vaccine By Associated Press Dr. Brett Giroir, an assistant secretary at the Department of Health and Human Services, told a Senate hearing he’d “have no hesitancy” to take that vaccine. Continue reading
Aug 28 Health agencies’ credibility at risk after week of blunders By Matthew Perrone, Ricardo Alonso-Zaldivar, Associated Press First, the head of the Food and Drug Administration had to walk back exaggerated statements about the benefits of a new plasma therapy for coronavirus. Then the Centers for Disease Control and Prevention triggered a backlash from the medical community… Continue reading
Aug 25 FDA chief apologizes for overstating plasma effect on coronavirus By Deb Reichmann, Matthew Perrone, Associated Press Responding to outcries from medical experts, Food and Drug Administration Commissioner Stephen Hahn is admitting he overstated the life-saving benefits of treating COVID-19 patients with convalescent plasma. Continue reading
Aug 19 FDA blocks much-anticipated BioMarin hemophilia gene therapy By Linda A. Johnson, Associated PRess Investors fled drug developer BioMarin in droves on Wednesday, driving shares down by a third after U.S. regulators rejected the company's potentially game-changing hemophilia A gene therapy. Continue reading
Jul 20 FDA calls for removal of fruity, disposable vapes By Matthew Perrone, Associated Press U.S. health officials are cracking down on a brand of fruity disposable e-cigarettes that is popular with teenagers, saying the company never received permission to sell them in the U.S. Continue reading
Jun 27 Watch 5:46 Why the race for a COVID-19 vaccine is complicated By PBS NewsHour Pharmaceutical companies and governments around the world are chasing a coronavirus vaccine, fast tracking the usually years-long vaccine development procedure to a few months. ProPublica reporter Caroline Chen joins Hari Sreenivasan to discuss the ambitious timeline and the unpredictability of… Continue watching
May 29 FDA finds contamination in several brands of diabetes drug By Matthew Perrone, Associated Press Several batches of the drug metformin tested positive for a chemical that likely contributes to cancer. The announcement late Thursday follows dozens of heartburn drug recalls in the last year linked to the same contaminant. Continue reading