Phathom Pharmaceuticals says it will resubmit an NDA for vonoprazan for treating erosive esophagitis, and a post-approval supplement for Voquezna Trip...
FDA accepts for review two Pfizer Supplemental NDAs for Braftovi (encorafenib) and Mektovi (binimetinib) and their use in patients with metastatic non...
CDER issues an updated MAPP for Office of Clinical Pharmacology IND review processes.
FDA posts a draft guidance entitled Human User Safety in New and Abbreviated New Animal Drug Applications to inform sponsors of the types of informati...
Abbott issues a safety notice for the Readers and batteries used as part of the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash g...
OncoSec says its Tavo-EP in combination with Mercks Keytruda failed to meet the overall response rate primary endpoint in a Phase 2 trial with some me...
FDA warns Fullerton, CA-based Synovo Production about its manufacturing and distribution of adulterated and misbranded orthopedic medical devices.
Lilly researchers say FDA was consistent in meeting its mid-cycle communication goals under a 2012 program to educate regulatory professionals about t...
