FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
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...

latest-news-card-1
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.

latest-news-card-1
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.

latest-news-card-1
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 ...

latest-news-card-1
Human Drugs

FDA Misses Review Decision on Stealth Bio NDA

FDA misses a 4/29 user fee review action extension on a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeut...

latest-news-card-1
Human Drugs

Amazon Selling Unapproved, Misbranded Drugs: FDA

FDA warns Amazon it is marketing unapproved and misbranded external analgesic drug products for use before sensitive cosmetic procedures.

latest-news-card-1
Human Drugs

CGMP Issues at BEO Pharmaceuticals

FDA warns Brooksville, FL-based BEO Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.

latest-news-card-1
Biologics

Abeona Gains Approval of Resubmitted Zevaskyn

FDA approves Abeona Therapeutics Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, an autologous cell-based gene therapy for treating ...

latest-news-card-1
Medical Devices

Learn from Exer Labs Warning on AI Use: Attorneys

Two Hogan Lovells attorneys discuss lessons medical device companies can learn about AI use from a recent FDA Warning Letter to Exer Labs.

latest-news-card-1
Biologics

Trial Shows Value of Immunotherapy in Some Cancers

A Memorial Sloan Kettering Cancer Center Phase 2 trial demonstrates the value of immunotherapy in MMRd genetic mutation cancers instead of surgery, ra...