FDA updates a Baxter recall (device correction) of its MiniCap Extended Life PD Transfer Sets used in hemodialysis.
FDA accepts for review a supplemental NDA for Nucala (mepolizumab) and its use as an add-on maintenance treatment for patients with chronic obstructiv...
FDA approves a Cumberland Pharmaceuticals supplemental NDA for a simplified dosing regimen of its Acetadote (N-acetylcysteine for injection).
Merck says a Phase 3 KEYLYNK-001 trial evaluating Keytruda (pembrolizumab) plus chemotherapy followed by maintenance with Lynparza (olaparib) met the...
Agios files a supplemental NDA for an expanded indication for its Pyrukynd (mitapivat) for treating adult patients with alpha- or beta-thalassemia.
FDA clears an AngioDynamics 510(k) for the NanoKnife System for prostate tissue ablation.
AbbVie announces positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as an early Parkinson's disease therapy.
Chimerix plans to submit an NDA before the end of the year seeking accelerated approval for dordaviprone for treating recurrent H3 K27M-mutant diffuse...
