FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend approval of a Pfizer BLA for its Abrysvo (RSVpreF) vaccine for pre...
FDA publishes two guidances to assist in the development of drugs, biologics, and vaccines for pediatric use.
FDA modifies a partial clinical hold on an Avidity Biosciences study involving AOC 1001, allowing Avidity to double the number of participants in the ...
ICU Medical recalls the replacement batteries in its in Plum A+ & Plum A+3 Infusion Systems due to a manufacturing defect by a battery supplier.
Federal Register notice: FDA posts its annual compilation of notices of updates to the agencys antimicrobial test interpretive criteria Web page.
Federal Register notice: CDRH plans a 9/6 Patient Engagement Advisory Committee meeting that will discuss and make recommendations on advancing health...
FDA asks the Gastrointestinal Drugs Advisory Committee whether it recommends approval of Intercepts obeticholic acid to treat pre-cirrhotic liver fibr...
A bipartisan group of members of Congress introduce legislation to redirect penalties paid by drug, cosmetic, supplement, and medical device companies...
