FDA approves a Novartis supplemental NDA to expand the indication for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to include adults with prostate...
FDA notifies NDA and ANDA holders about data integrity and study conduct concerns involving bioequivalence studies conducted at India-based contract r...
FDA accepts for review a Liquidia NDA resubmission for Yutrepia (treprostinil) inhalation powder to treat pulmonary arterial hypertension and pulmonar...
FDA approves a Sanofi NDA for Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatr...
The Autism Self-Advocacy Network sharply criticizes HHS for hiring quack David Geier to study a potential link between autism and vaccines, which the ...
A bipartisan group of five Senate Judiciary Committee members introduces legislation to establish an FDA/Patent and Trademark Office task force to imp...
HHS says FDA will lose about 3,500 (18%) of its 19,000 full-time employees under a just-announced reductions in force plan to consolidate activities a...
An exclusive Reuters report says FDA is likely to miss medical device user fee deadlines due to staff shortages from two rounds of cuts mandated by th...
