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FDA accepts for priority review a Denali Therapeutics BLA for tividenofusp alfa for treating Hunter syndrome.[ Price : $8.95]
A ProPublica investigative report says FDA inspectors continue to have issues arising from the dismissal of many of their support ...[ Price : $8.95]
FDA accepts and will give priority review to a Merck sBLA for a Winrevair labeling update based on ZENITH trial results.[ Price : $8.95]
Former FDA commissioner Scott Gottlieb raises significant questions about the current administrations handling of vaccines and vac...[ Price : $8.95]
FDA says Sandoz has recalled one lot of Cefazolin for injection following a customer complaint that vials of another drug were inc...[ Price : $8.95]
FDA clears Philips SmartSpeed Precise AI-enhanced software for MRI systems.[ Price : $8.95]
FDA publishes a draft guidance to assist sponsors in developing drugs to treat myelodysplastic syndromes.[ Price : $8.95]
Moderna says its mRNA-1010 investigational seasonal flu vaccine achieved very positive results in a Phase 3 efficacy trial.