CDERs Office of Prescription Drug Promotion (OPDP) faults a Novartis direct-to-consumer TV ad promoting it breast cancer therapy Kisqali (ribociclib) ...
Ionis Pharmaceuticals plans an NDA submission based on data from the Phase 3 OASIS-HAE study in people with hereditary angioedema.
FDA lifts a clinical hold against a Pharvaris IND for deucrictibant, an investigational therapy for the prophylactic treatment of hereditary angioedem...
FDA posts a draft guidance entitled Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices.
FDA accepts for priority review a Genentech supplemental BLA for Xolair (omalizumab) for reducing allergic reactions, including anaphylaxis, that may ...
FDA grants Bone Health Technologies a de novo marketing authorization for its Osteoboost, the first non-pharmacological device-based prescription trea...
Gilead Sciences says its Trodelvy Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival in previously treated patients with met...
FDA clears a Kallisio 510(k) for Stentra, a 3D-printed oral stent designed to protect healthy tissue in head and neck cancer patients.
