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
May 28 Doctors sue to block FDA abortion pill rule during pandemic By Michael Kunzelman, Associated Press Requiring patients to visit a hospital, clinic or medical office to get an abortion pill is needlessly risking their health during the COVID-19 pandemic, a group of physicians allege in a lawsuit that seeks to suspend the federal rule. Continue reading
May 09 US approves new coronavirus antigen test with fast results By Tom Krisher, Associated Press The Food and Drug Administration on Saturday announced emergency authorization for antigen tests developed by Quidel Corp. of San Diego. The test can rapidly detect fragments of virus proteins in samples collected from swabs swiped inside the nasal cavity, the… Continue reading
May 08 U.S. approves at-home saliva-based virus test By Associated Press U.S. health regulators approved the first saliva-based coronavirus test that allows people to collect their own sample at home. Continue reading
May 01 FDA allows emergency use of drug for coronavirus By Associated Press U.S. regulators will allow emergency use of an experimental drug that appears to help some coronavirus patients recover faster. Continue reading
Apr 24 FDA warns of heart risks with Trump-promoted malaria drug By Matthew Perrone, Associated Press, Marilynn Marchione, AP Chief Medical Writer The U.S. Food and Drug Administration is warning doctors against prescribing a malaria drug widely touted by President Donald Trump for treating the new coronavirus outside of hospitals or research settings. Continue reading