FDA says a required post-accelerated approval trial of Oncopeptides Pepaxto found an increased risk of death.
Federal Register notice: FDA announces the fiscal year 2022 user fee rates for the establishment and reinspection fees related to entities that compou...
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.