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Two stakeholders suggest changes to an FDA draft guidance on protocol deviations in clinical studies.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...
FDA approves a Celltrion BLA for Stoboclo (denosumab-bmwo), a biosimilar to Amgens Prolia, and Osenvelt (denosumab-bmwo), a biosimilar to Amgens Xgeva...
Wired reports that several FDA-regulated companies have informed the Securities and Exchange Commission that their business could be adversely affecte...