FDA accepts for priority review an Eisai and Biogen supplemental BLA for Leqembi (lecanemab-irmb) 100 mg/mL injection that is intended to convert the ...
Lawyers from Troutman Pepper say that two recent medical product cases could be a harbinger of more Department of Justice deferred prosecution agreeme...
FDA announces a 4/12 Nonprescription Drugs Advisory Committee meeting to discuss the adequacy of efficacy data available for over-the-counter use of o...
Exelixis says its Phase 3 CONTACT-03 study evaluating the companys Cabometyx (cabozantinib) in combination with atezolizumab versus cabozantinib alone...
Federal Register notice: FDA makes available a final guidance entitled Q13 Continuous Manufacturing of Drug Substances and Drug Products.
Federal Register notice: FDA makes available a draft guidance entitled Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Pr...
FDA declines a Veru request for an Emergency Use Authorization for sabizabulin, a microtubule disruptor for treating Covid-19 hospitalized adult patie...
FDA approves an expanded indication for Eli Lillys Verzenio (abemaciclib), in combination with endocrine therapy for the adjuvant treatment of adult p...
