FDA Related News

Human Drugs

Lawmakers Urge FDA to Block Super Bowl Drug Ad

Senators Dick Durbin (D-IL) and Roger Marshall (R-KS) call on FDA to take enforcement action against a planned direct-to-consumer commercial that will...

Medical Devices

RapidAI Wins Clearance for Lumina 3D

FDA clears a RapidAI 510(k) for its Lumina 3D, an automated 3D imaging reconstruction device designed to replace manual workflows.

Biologics

Adicet Wins Fast Track for Lupus Cell Therapy

FDA grants Adicet Bio a fast-track designation for ADI-001 and its use in treating adult patients with refractory systemic lupus erythematosus with ex...

Medical Devices

FDA Alert on Breast Implant Illness

FDA alerts healthcare professionals and patients about medical device reports detailing breast implant illness with systemic symptoms that have been r...

Human Drugs

AbbVie Antibiotic OKd for Abdominal Infections

FDA approves an AbbVie NDA for Emblaveo (aztreonam and avibactam), a combination antibiotic for combination use with metronidazole in patients with co...

FDA General

Senate Dems Denounce FDA Communication Freeze

A group of 24 Senate Democrats write HHS and urge an end to the ongoing and unprecedented freeze on all external communications and funding at governm...

Human Drugs

Insmed NDA Accepted for Brensocatib

FDA accepts for priority review an Insmed NDA for brensocatib for treating patients with non-cystic fibrosis bronchiectasis.

Medical Devices

Alert on Bards Rotarex Atherectomy System

FDA issues an alert about Bard Peripheral Vasculars Rotarex Atherectomy Systems due to risks of fracture or breakage.

Human Drugs

Use Preemption in Failure-to-Market Cases: PRI

A Pacific Research Institute white paper makes the case for a preemption defense in failure-to-market cases brought under state laws.

Court Threatens Practice of Medicine Defense: Attorneys

Cooley attorneys say a recent 4th Circuit Court of Appeals decision threatens the practice of medicine defense, giving FDA an additional enforcement m...