FDA Related News

Human Drugs

FDA Taps Murphy to Head Generic Drugs Office

FDA names CDER Office of Generic Drugs safety and clinical evaluation acting director Iilun Murphy as the next OGD director, replacing Sally Choe, who...

Human Drugs

FDA Approves Production at BMS CAR T Facility

FDA greenlights commercial production of CAR T cell therapy at a new Bristol Myers Squibb manufacturing site in Devens, MA.

Human Drugs

Panel Backs RSV Monoclonal Antibody

FDAs Antimicrobial Drugs Advisory Committee votes unanimously that AstraZeneca and Sanofis nirsevimab has a favorable benefit-risk assessment for prev...

Create One PPI Guidance for all Products: Novartis

Novartis urges FDA to broaden its proposal on patient preference information beyond medical devices.

Human Drugs

Assessing GDUFA User Fees Guidance

FDA publishes a guidance with specifics about changes to user fees imposed under the GDUFA 3 reauthorization in 2022.

Human Drugs

FDA OKs Novaliq Dry Eye Drug

FDA approves a Novaliq NDA for Vevye (cyclosporine ophthalmic solution) 0.1% for treating the signs and symptoms of dry eye disease.

Human Drugs

FDA Ups Pediatric Exclusivity Requirements: Attorneys

Two SheppardMullin attorneys describe how two recent FDA guidances on pediatric drug development will tighten eligibility for pediatric exclusivity.

Human Drugs

FibroGens Pamrevlumab Fails Phase 3

FibroGen says its pamrevlumab failed to meet the primary endpoint in treating Duchenne Muscular Dystrophy in a Phase 3 trial.

Medical Devices

AdvaMed Recommendations for Patient Preference

AdvaMed says it agrees with FDA on questions to be added to a guidance on the submission of patient preference information, and also recommends change...

Medical Devices

Teleflex Pacing Guidewire Cleared

FDA clears a Teleflex 510(k) for its Wattson Temporary Pacing Guidewire a bipolar temporary device designed specifically for use during transcatheter...