FDA grants Visby Medical a de novo marketing clearance for its Womens Sexual Health Test, a non-prescription at-home diagnostic test for chlamydia, go...
FDA reschedules for 5/4 a previously planned joint advisory committee meeting on studies that looked at the use of opioid analgesics for management of...
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...
FDA sends Milestone Pharmaceuticals a complete response letter on its NDA for Cardamyst (etripamil) nasal spray and its use to convert acute episodes ...
FDA clears a Vasorum 510(k) for the Celt ACD Plus vascular closure device.
