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Federal Register notice: FDA announces a 12/13 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Cytokinetics ...[ Price : $8.95]
FDA publishes a guidance with updated GDUFA 3 information on information requests and discipline review letters.[ Price : $8.95]
FDA publishes a guidance with information on competitive generic therapies.[ Price : $8.95]
GlaxoSmithKline announces positive results from the Phase 2 PERLA trial of its lung cancer drug Jemperli.[ Price : $8.95]
FDA will not hold a pre-EUA meeting with Eigen BioPharmaceuticals on its possible use of peginterferon lambda to treat Covid-19.[ Price : $8.95]
FDA publishes a guidance incorporating GDUFA 3 reauthorization performance goals for post-complete response letter clarification t...[ Price : $8.95]
Washington Legal Foundation says a California trial court erred in ruling that Gilead could be held liable for not developing a di...[ Price : $8.95]
CBER publishes four Standard Operating Policies and Procedures relating to application review responsibilities for various product...