FDA Related News

Human Drugs

Braeburn Wants Sublocade Orphan Designation Dropped

Braeburn asks FDA to revoke the orphan drug designation for Invidiors opioid use disorder drug Sublocade.

Human Drugs

Zogenix Given Refusal to File on Fintepla NDA

FDA issues Zogenix a refusal to file letter for its for Fintepla (fenfluramine hydrochloride) for treating seizures associated with Dravet syndrome.

Medical Devices

Innoblative Designs Sira RFA Electrosurgical Device Cleared

FDA clears an Innoblative Designs 510(k) for Sira RFA Electrosurgical Device, a novel radiofrequency ablation applicator that supplies energy for use ...

Federal Register

Comments Extended on Tobacco Compliance Policy Guide

Federal Register notice: FDA extends the comment period on a draft guidance entitled Modifications to Compliance Policy for Certain Deemed Tobacco Pro...

Medical Devices

Myriad Genetics PMA Module for Companion Diagnostic

Myriad Genetics files the first module of a planned PMA for the myChoice HRD CDx test, a companion diagnostic for identifying certain patients with ov...

4 Major Issues Facing Sharpless: Attorneys

Three DIA Piper attorneys describe four key issues facing FDA acting commissioner Norman Sharpless.

Human Drugs

Companies Comment on Esophagitis Drug Development

Two drug companies offer suggestions for an FDA draft guidance on developing drugs to treat eosinophilic esophagitis.

Human Drugs

FDA Approves Evenity for Osteoporosis

FDA approves Amgen/UBS Evenity to treat osteoporosis in postmenopausal women at high risk of fracture.

Human Drugs

FDA Changing Opioid Labeling on Tapering Off Drugs

FDA says it is ordering changes to labeling for opioids used in outpatient settings to help providers and patients safety decrease the dose or wean of...

Relieveus Selling Unapproved CBD Products: FDA

FDA and FTC warns Relieveus that it is marketing CBD markets online that are unapproved and misbranded new drugs and are subject to FTC advertising re...