FDA announces two new pilot programs that the International Coalition of Medicines Regulatory Authorities (ICMRA), of which the agency is a member, is...
Gilead Sciences refiles an NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for treating HIV-1 infection in heavily treatm...
FDAs Vaccines and Related Biological Products Advisory Committee votes 19 to 2 to recommend that the SARS-CoV-2 strain composition of Covid-19 vaccine...
FDA clears an Acutus Medical 510(k) for an expanded suite of left-heart access products to include the AcQCross Qx system for use with the TruSeal and...
Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide The...
FDA clears an Altamira Therapeutics 510(k) to market its nasal spray Bentrio for treating allergic rhinitis.
Federal Register notice: FDA sends to OMB an information collection entitled Pilot Survey to Develop Standardized Reporting Forms for Federally Funded...
FDA proposes to expand options for drug companies seeking to market a nonprescription drug product to allow an additional condition for potential nonp...