FDA Related News

Biologics

Makary Suggests Raising Bar on Covid Boosters

FDA commissioner Marty Makary suggests more data could be required for Covid-19 vaccine boosters this winter.

FDA General

Little Trust in New Health Leaders: Poll

A poll from the Harvard University T.H. Chan School of Public Health finds that more Americans say they will be trusting public health agencies less i...

FDA General

FDA Layoffs Affect Product Development: Post

Skadden attorneys say the FDA reduction in force should have the greatest negative impact on products that are in development.

Human Drugs

FDA OKs J&Js Imaavy for Myasthenia Gravis

FDA approves a Johnson & Johnson BLA for Imaavy (nipocalimab-aahu) for treating generalized myasthenia gravis.

FDA General

Unanimous SCOTUS Decision Reassuring: Post

George Washington University law professor Richard Pierce praises a recent unanimous Supreme Court decision backing FDA in an e-cigarette regulation c...

Human Drugs

Boehringer Drug Shows Encouraging Data in Lung Cancer

Boehringer Ingelheim releases new findings from its Beamion LUNG-1 trial, highlighting the potential of zongertinib as a breakthrough oral therapy for...

No Broad FDA Reorganization Coming: Makary

In a wide-ranging Inside Medicine Substack interview, FDA commissioner Martin Makary says there will be no broad reorganization at the agency, althoug...

Human Drugs

Senator Hawley Urges FDA Action on Mifepristone Study

Senator Josh Hawley (R-Mo.) urges FDA commissioner Marty Makary to review a new study allegedly revealing greater safety risks than the agency current...

Human Drugs

Cosco International CGMP Inspection Findings

FDA warns Marietta, GA-based Cosco International about CGMP violations in its production of unapproved and misbranded drugs.

Marketing

Bill Seeks to Kill Tax Deductions for DTC Ad Expenses

A group of bipartisan House lawmakers introduce the No Handouts for Drug Advertisements Act, a bill that would prohibit tax deductions for the annual ...