FDA issues a safety alert on using robotically-assisted surgical devices in womens health procedures, including mastectomy and other cancer-related su...
FDA approves a Janssen Pharmaceutical supplemental BLA for Tremfya (guselkumab) One-Press, a single-dose, patient-controlled injector for adults with ...
FDA says orphan drug exclusivity ordered by a federal court for Eagles Bendeka extends to all applications containing bendamustine, the active moiety ...
CDERs Office of Pharmaceutical Quality says it saw record drug approval numbers in 2018.
FDA commissioner Scott Gottlieb outlines for U.S. House of Representative appropriators significant modernization efforts underway in CDERs Office of ...
Parexel International hires former FDA Oncology Center of Excellence deputy director Amy McKee as regulatory consulting services vice president.
FDA approves Genentechs Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) subcutaneous injection for treating patients with HER2-positive early b...
Federal Register notice: FDA announces a public meeting and an opportunity for public comment on Patient Perspectives on the Impact of Rare Diseases: ...