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 ...
FDA and drug-industry negotiators exchange early feedback on the agencys proposed America First fee incentives for domestic drug development during a ...
FDA approves Janssens Akeega a fixed-dose combination of niraparib and abiraterone acetate with prednisone for adults with metastatic castration-sen...
FDA considers adding a Boxed Warning to Covid-19 vaccines, the latest action as part of an ongoing campaign to scrutinize and restrict use of the vacc...
