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FDA places a clinical hold on BioNTechs Phase 1/2a dose escalation clinical trial evaluating an investigational RNA-based vaccine ...[ Price : $8.95]
FDA approves an ARS Pharmaceuticals supplemental NDA for Neffy (epinephrine nasal spray 1mg) for treating Type I allergic reaction...[ Price : $8.95]
FDA warns Indias Granules India Limited about CGMP violations in its production of finished drugs.[ Price : $8.95]
Two stakeholders suggest changes to an FDA draft guidance on protocol deviations in clinical studies.[ Price : $8.95]
The ethics form submitted to HHS by FDA commissioner nominee Martin Makary says he will resign his position at Johns Hopkins Unive...[ Price : $8.95]
FDA warns Pleasantville, IA-based Chem-Tech about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA accepts for priority review a Capricor Therapeutics BLA for deramiocel, a cell therapy for treating patients diagnosed with Du...[ Price : $8.95]
FDA approves a Celltrion BLA for Stoboclo (denosumab-bmwo), a biosimilar to Amgens Prolia, and Osenvelt (denosumab-bmwo), a biosim...