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FDA publishes a draft guidance on characterizing metallic or calcium phosphate coatings on Class 2 and 3 orthopedic medical device...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion (OPDP) faults a Novartis direct-to-consumer TV ad promoting it breast cancer therapy K...[ Price : $8.95]
Ionis Pharmaceuticals plans an NDA submission based on data from the Phase 3 OASIS-HAE study in people with hereditary angioedema.[ Price : $8.95]
FDA lifts a clinical hold against a Pharvaris IND for deucrictibant, an investigational therapy for the prophylactic treatment of ...[ Price : $8.95]
FDA posts a draft guidance entitled Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices....[ Price : $8.95]
FDA accepts for priority review a Genentech supplemental BLA for Xolair (omalizumab) for reducing allergic reactions, including an...[ Price : $8.95]
FDA grants Bone Health Technologies a de novo marketing authorization for its Osteoboost, the first non-pharmacological device-bas...[ Price : $8.95]
Gilead Sciences says its Trodelvy Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival in previously treat...