FDA Related News

FDA, FTC Should Regulate Influencer Posts: Column

A StatNews column calls for FDA and FTC collaboration to regulate social media videos and comments from influencers on prescription drugs.

Medical Devices

Orthopedic Device Coatings Guidance

FDA publishes a draft guidance on characterizing metallic or calcium phosphate coatings on Class 2 and 3 orthopedic medical devices.

Marketing

OPDP Letter Cites Novartis on Kisqali Ad

CDERs Office of Prescription Drug Promotion (OPDP) faults a Novartis direct-to-consumer TV ad promoting it breast cancer therapy Kisqali (ribociclib) ...

Human Drugs

Ionis Plans NDA for Donidalorsen

Ionis Pharmaceuticals plans an NDA submission based on data from the Phase 3 OASIS-HAE study in people with hereditary angioedema.

Human Drugs

Pharvaris Clinical Hold Lifted

FDA lifts a clinical hold against a Pharvaris IND for deucrictibant, an investigational therapy for the prophylactic treatment of hereditary angioedem...

Medical Devices

Draft Guide on Orthopedic Device Coatings

FDA posts a draft guidance entitled Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices.

Biologics

Priority Review for Xolair Food Allergy sBLA

FDA accepts for priority review a Genentech supplemental BLA for Xolair (omalizumab) for reducing allergic reactions, including anaphylaxis, that may ...

Medical Devices

De Novo OK for Osteopenia Device

FDA grants Bone Health Technologies a de novo marketing authorization for its Osteoboost, the first non-pharmacological device-based prescription trea...

Human Drugs

Gilead Trodelvy Trial Misses Endpoint

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...

Medical Devices

Kallisio Oral Stent Cleared

FDA clears a Kallisio 510(k) for Stentra, a 3D-printed oral stent designed to protect healthy tissue in head and neck cancer patients.