FDA accepts a Shire BLA for calaspargase pegol (Cal-PEG; SHP663), indicated as a component of a multi-agent chemotherapeutic regimen for treating pati...
FDA approves a Medtronic PMA supplement for a new arm indication for the Guardian Sensor 3 glucose monitor that will enable patients to wear the senso...
FDA approves a Scilex Pharmaceuticals NDA for ZTlido (lidocaine topical system) 1.8%, indicated for relieving pain associated with post-herpetic neura...
CDRHs Malvina Eydelman touts the early successes of the new Breakthrough Device Program created under the 21st Century Cures Act.
Federal Register notice: FDA announces a 3/29-30 Clinical Chemistry and Clinical Toxicology Devices Panel meeting.
FDA posts an International Council for Harmonization guidance on E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1) that provides a un...
FDA issues Celgene a refusal-to-file letter on an NDA for ozanimod for treating patients with relapsing forms of multiple sclerosis.
Federal Register notice: FDA submits for OMB approval an information collection extension for Guidance for Industry, Researchers, Patient Groups, and ...