FDA clears Pentax Medical 510(k)s for new endoscope models for colonoscopy and upper GI use.
Federal Register notice: FDA makes available a guidance entitled Standardized Format for Electronic Submission of NDA and BLA Content for the Planning...
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.
