FDA Related News

Human Drugs

Reopen FDA San Juan Lab: Representatives

Reps. Alexandria Orcasio-Cortez and Nydia Velzquez ask HHS secretary Robert F. Kennedy, Jr., to reopen the FDA San Juan medical products laboratory th...

Human Drugs

Immunic Reports Positive Data on MS Drug

Immunic reports positive data from its Phase 2 CALLIPER trial of nuclear receptor related 1 activator vidofludimus calcium (IMU-838) in patients with ...

Human Drugs

Gilead Pays $202 Million Over Kickbacks Scheme

Gilead Sciences agrees to pay $202 million to resolve claims that the company offered and paid kickbacks (e.g., honoraria payments, meals, and travel ...

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...