FDA grants Purdue Pharma a fast track designation for nalmefene hydrochloride injection, an investigational opioid antagonist for the emergency treatm...
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Brain Metastases.
Federal Register notice: FDA makes available a final guidance entitled Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clini...
FDA issues an FDA-483 with four observations from an Immunomedics inspection.
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or ...
Janssen Pharmaceutical files a supplemental BLA for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for treating patients wi...
FDA approves an Aerie Pharmaceuticals NDA for Rocklatan (netarsudil and latanoprost) ophthalmic solution) 0.02%/0.005% to reduce elevated intraocular ...
CDRH begins implementing a reorganization that will combine the Office of Compliance, Office of Device Evaluation, Office of Surveillance and Biometri...