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Federal Register notice: FDA makes available a draft guidance entitled Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Pr...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...
FDA clears a FloSpine 510(k) for its a 3D-printed titanium Ti-Largo cervical interbody cage system to support the spine after a cervical collapse or a...
FDA cleared a Convatec 510(k) for its InnovaMatrix PD particulate placental extracellular matrix medical device for wound management.
FDA publishes the CDER Drug Safety 2002 Priorities Report reviewing the many drug safety activities the Center undertook in 2022.
