Federal Register notice: FDA announces a 12/13 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Cytokinetics NDA for omecamtiv me...
FDA publishes a guidance with updated GDUFA 3 information on information requests and discipline review letters.
FDA publishes a guidance with information on competitive generic therapies.
GlaxoSmithKline announces positive results from the Phase 2 PERLA trial of its lung cancer drug Jemperli.
FDA will not hold a pre-EUA meeting with Eigen BioPharmaceuticals on its possible use of peginterferon lambda to treat Covid-19.
FDA publishes a guidance incorporating GDUFA 3 reauthorization performance goals for post-complete response letter clarification teleconferences.
Washington Legal Foundation says a California trial court erred in ruling that Gilead could be held liable for not developing a different HIV/AIDS dru...
CBER publishes four Standard Operating Policies and Procedures relating to application review responsibilities for various products.
