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FDA clears Pentax Medical 510(k)s for new endoscope models for colonoscopy and upper GI use.[ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled Standardized Format for Electronic Submission of NDA and BLA Cont...[ Price : $8.95]
FDA updates a Baxter recall (device correction) of its MiniCap Extended Life PD Transfer Sets used in hemodialysis.[ Price : $8.95]
FDA accepts for review a supplemental NDA for Nucala (mepolizumab) and its use as an add-on maintenance treatment for patients wit...[ Price : $8.95]
FDA approves a Cumberland Pharmaceuticals supplemental NDA for a simplified dosing regimen of its Acetadote (N-acetylcysteine for ...[ Price : $8.95]
Merck says a Phase 3 KEYLYNK-001 trial evaluating Keytruda (pembrolizumab) plus chemotherapy followed by maintenance with Lynparza...[ Price : $8.95]
Agios files a supplemental NDA for an expanded indication for its Pyrukynd (mitapivat) for treating adult patients with alpha- or ...[ Price : $8.95]
FDA clears an AngioDynamics 510(k) for the NanoKnife System for prostate tissue ablation.