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 ...
FDA posts updated guidance calling on drug and biologics developers to broaden eligibility criteria, modernize enrollment practices, and adopt more fl...
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...
A new analysis from University of California (UC) Riverside and UC Irvine researchers finds that the vast majority of pivotal clinical trials used to ...
