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.
CDER director Patrizia Cavazzoni describes how FDA and FTC are working collaboratively to increase competition for biologic products.
Federal Register notice: FDA announces a 4/28 Oncologic Drugs Advisory Committee meeting to review an AstraZeneca supplemental NDA for Lynparza (olapa...
The Sedgwick 2022 recall report says both drug and medical device recall events surged higher in 2022, with drugs outpacing devices.
