New CDER director George Tidmarsh talks about hiring new reviewers, improving staff morale, and finding ways to safely speed drug approvals.
FDA grants fast-track designation to Alphamab Oncologys JSKN003 to treat several cancers.
A federal court ruling finds that FDA acted unlawfully by imposing certain REMS restrictions on mifepristone.
A Friends of Cancer Research working group suggests ways to overcome challenges in selecting standard of care comparators for oncology multi-regional ...
FDA releases the form FDA-483 with four observations from an inspection at the Zydus drug manufacturing facility in Baddi, India.
FDA issues a clinical hold on Intellia Therapeutics MAGNITUDE and MAGNITUDE-2 Phase 3 trials for nexiguran ziclumeran after the company disclosed Grad...
FDA grants Dewpoint Therapeutics an orphan drug designation for DPTX3186 and its use in potentially treating gastric cancer.
FDA clears a Tosoh Bioscience 510(k) for its next-generation Automated Glycohemoglobin Analyzer for rapid HbA1c (blood sugar) testing.
