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Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or ...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...
A New York federal judge says a whistleblower suit against a Teva speakers program for two drugs may proceed to trial.
FDA publishes five guidances intended to broaden eligibility criteria for drug and biological product clinical trials.
A Texas federal judge approves a consent decree sought by FDA against Guardian Pharmacy Services, a drug compounder.