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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...[ Price : $8.95]
Bayer pushes FDA to confirm that it will grant a 30-month stay before approving an Apotex ANDA for Bayers Astepro Allergy nasal sp...[ Price : $8.95]
FDA and researchers from New York University partner to design a regulatory science tool to improve the review processes for strok...