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.
Bayer pushes FDA to confirm that it will grant a 30-month stay before approving an Apotex ANDA for Bayers Astepro Allergy nasal spray.
FDA and researchers from New York University partner to design a regulatory science tool to improve the review processes for stroke rehabilitation dev...
FDA is soliciting projects to fund under a new pilot program to enhance regulatory science for biosimilars and interchangeable products.
