An FDA advisory committee unanimously votes to recommend Pfizer-BioNTechs Comirnaty Covid-19 booster vaccine in individuals 65 years of age and older ...
Federal Register notice: FDA makes available a final guidance entitled Questions and Answers on Biosimilar Development and the BPCI Act.
Pfizer expands its Chantix (varenicline) recall to include all lots of 0.5 mg and 1 mg tablets because of the potential presence of unacceptable N-nit...
An FDA safety alert warns healthcare professionals and patients not to use compounded products from Prescription Labs, doing business as Greenpark Com...
A Florida federal court enters a consent decree against Premier Pharmacy Labs that prohibits it from producing or distributing any drugs until the com...
FDA places a clinical hold against three Protagonist Therapeutics clinical studies for rusfertide due to concerning mouse study findings.
Massachusetts General Hospital researchers say FDA policy deviations for regulatory laboratory-developed tests during the Covid-19 pandemic give a clu...
FDA says changes to the clozapine REMS to ensure that the drugs benefits outweigh the risk of severe neutropenia take effect 11/15.