FDA commissioner Marty Makary says the agency has no plans to add a Black Box Warning to Covid vaccines, contradicting a report from last week saying ...
Vanda Pharmaceuticals files a BLA for imsidolimab and its use in treating generalized pustular psoriasis, a rare and potentially fatal inflammatory sk...
FDA proactively awards Johnson & Johnson a national priority voucher for teclistamab in combination with daratumumab for treating relapsed or refracto...
Sanofi says it will not seek FDA approval for tolebrutinib in primary progressive multiple sclerosis after the drug failed to meet its primary endpoin...
FDA says it is removing a long-standing barrier to the use of real-world evidence in regulatory reviews by accepting such data without requiring ident...
FDA posts two final guidances that provide recommendations to help clinical investigators comply with the safety reporting requirements for IND and ID...
The Government Accountability Office urges HHS to shore up staffing and reassess legal authorities at FDA after finding significant weaknesses in how ...
FDA approves Daiichi Sankyos Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Genentechs pertuzumab as a first-line treatment for adults ...
