FDA Related News

Human Drugs

Court Allows 1 Vanda Claim Against FDA

The U.S. Court of Federal Claims says one part of a Vanda claim against FDA involving the agencys actions in reviewing generic drug applications for t...

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FDA publishes a draft guidance on characterizing metallic or calcium phosphate coatings on Class 2 and 3 orthopedic medical devices.

Human Drugs

Vanda Gets IND OK for Rare Disease

FDA approves a Vanda Pharmaceuticals IND to evaluate VCA-894A for treating patients with Charcot-Marie-Tooth disease, axonal, Type 2S.

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FDA posts a draft guidance entitled Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices.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