FDA Related News

SCOTUS Chevron Decision Harms the Public: Coalition

The Coalition for Sensible Safeguards calls on Congress to enact Chevron deference into law following a Supreme Court decision gutting the 40-year-old...

Medical Devices

Abbott Recalls HeartMate System Monitor

Abbott Medical recalls (Class 1) its HeartMate System Monitor due to atypical behavior of the System Monitor screen.

Biologics

Complete Response on Rocket Gene Therapy

FDA issues Rocket Pharmaceuticals a complete response letter on its BLA for gene therapy Kresladi (marnetegragene autotemcel; marne-cel) for treating ...

Human Drugs

Shorla Oncology Breast/Ovarian Cancer Drug OKd

FDA approves a Shorla Oncology NDA for Tepylute (thiotepa), a ready-to-dilute formulation for treating breast and ovarian cancer.

Human Drugs

Promising Myasthenia Gravis Trial Data: J&J

Johnson & Johnson reports positive data from its Phase 3 Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia gravis.

Human Drugs

Praise for Biological Labeling Draft Guidance

The Biosimilars Council and Biosimilars Forum praise a revised FDA draft guidance on biosimilar promotional labeling.

Human Drugs

Brookfield Medical/Surgical FDA-483

FDA releases the form FDA-483 with four observations from an inspection at the Brookfield, CT-based Brookfield Medical/Surgical Supplies outsourcing f...

Animal Drugs

Dog Heartworm Prevention Drug Guidance

FDA publishes a guidance with additional details on earlier guidances on evaluating the effectiveness of drugs indicated to treat heartworm in dogs.

Human Drugs

6 Observations in Cipla FDA-483

FDA releases the form FDA-483 with six observations from an inspection at a Goa, India, Cipla drug manufacturing facility.

FDA General

FDA Opening Office in Rwanda

FDA associate commissioner for global policy and strategy Mark Abdoo says the agency will support the African Medicines Agency through a new office in...