An Ohio State University business school study finds that generic drugs made in India are 54% more likely to be associated with serious adverse events...
FDA places a clinical hold on BioNTechs Phase 1/2a dose escalation clinical trial evaluating an investigational RNA-based vaccine (BNT165e) for preven...
FDA approves an ARS Pharmaceuticals supplemental NDA for Neffy (epinephrine nasal spray 1mg) for treating Type I allergic reactions in children who ar...
FDA warns Indias Granules India Limited about CGMP violations in its production of finished drugs.
Two stakeholders suggest changes to an FDA draft guidance on protocol deviations in clinical studies.
The ethics form submitted to HHS by FDA commissioner nominee Martin Makary says he will resign his position at Johns Hopkins University upon confirmat...
FDA warns Pleasantville, IA-based Chem-Tech about CGMP violations in its manufacturing of finished drugs.
FDA accepts for priority review a Capricor Therapeutics BLA for deramiocel, a cell therapy for treating patients diagnosed with Duchenne muscular dyst...