FDA clears a TrainHealth 510(k) for its TrainFES neuromuscular stimulator and its use in treating people with sequelae of stroke and spinal cord injur...
Eastern Texas federal judge Sean Jordan rules against FDA in a case challenging the agencys final rule regulating laboratory-developed tests.
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...
