FDA accepts for priority review a Mycovia Pharmaceuticals an NDA for oteseconazole, an oral antifungal for treating chronic yeast infection.
FDA advisory committee member G. Caleb Alexander lists the several ways he believes the agency erred in its accelerated approval of Biogens Aduhelm to...
FDA approves a Synchron IDE for its Stentrode motor neuroprosthesis.
FDA grants Apic Bio a fast track designation for APB-102, a gene therapy candidate designed to treat SOD1 amyotrophic lateral sclerosis.
The International Council for Harmonization says its Q13 guidance on drug continuous manufacturing is available for public comment.
Federal Register notice: FDA announces the generic drug user fee rates for fiscal year FY 2022.
Federal Register notice: FDA issues a five-year debarment order against Justin Ash due to his felony conviction for illegal importation of a drug or c...
FDA issues a draft guidance to help sponsors develop anti-rabies virus monoclonal antibody cocktails.