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...
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.
Federal Register notice: FDA corrects a 12/13/2018 notice entitled Data Integrity and Compliance With Drug CGMP: Questions and Answers; Guidance for I...
Federal Register notice: FDA seeks comments on an information collection extension for Information To Accompany Humanitarian Device Exemption Applicat...
Federal Register notice: FDA seeks comments on an information collection extension for Evaluation of the Program for Enhanced Review Transparency and ...