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FDA says it will exercise enforcement discretion for some modifications to molecular influenza tests during the Covid-19 pandemic.[ Price : $8.95]
An FDA reinspection at a troubled Eli Lilly drug manufacturing plant in Branchburg, NJ finds additional GMP problems that could po...[ Price : $8.95]
Bayer files a supplemental NDA seeking to extend the duration of use for up to seven years for its intrauterine device Mirena (lev...[ Price : $8.95]
FDA warns five dietary supplement manufacturers that they are producing products containing cesium chloride without meeting agency...[ Price : $8.95]
FDA commissioner Stephen Hahn promises that all Covid-19 decisions in the future will be based on science and data, and not politi...[ Price : $8.95]
FDA accepts for review a Biohaven Pharmaceutical Holding supplemental NDA for Nurtec ODT (rimegepant) for preventing migraines.[ Price : $8.95]
FDA places a clinical hold on a Voyager Therapeutics planned clinical trial for VY-HTT01 for treating Huntingtons disease.[ Price : $8.95]
Researchers say FDA could ensure better evidence in medical device de novo clearances by requiring that devices meet prespecified ...