Bloomberg News reports that FDA inspectors found problems at a Catalent Indiana facility that is being bought by Novo Nordisk to expand the supply of ...
FDA approves a Veru IND to begin a Phase 2b clinical study to evaluate enobosarm and its use in preserving muscle mass and physical function and incre...
Insight Pharmaceuticals recalls two lots of its TING 1% Tolnaftate Athletes Foot Spray Antifungal Spray Liquid due to elevated benzene levels.
A federal court sentences Arizona-based Centera Bioscience and CEO Paul Eftang for distributing unapproved drugs into interstate commerce.
Johnson & Johnson reports positive data from two studies involving its monoclonal antibody nipocalimab, supporting the drugs potential use in generali...
FDA posts a final guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.
Ainos files a clinical hold response seeking to begin a Phase 2 trial of its low-dose oral interferon (IFN)-alpha formulation Veldona.
Federal Register notice: FDA announces a 3/21 advisory committee meeting to discuss a de novo marketing request by Balance Ophthalmics for its intraoc...