FDA tightens Duchenne gene therapy after deaths of two teens

The U.S. Food and Drug Administration is tightening restrictions on a gene therapy used to treat Duchenne muscular dystrophy ...

UnitedHealth names former US FDA chief Scott Gottlieb to its board

UnitedHealth Group said on Tuesday it had named former U.S. Food and Drug Administration commissioner Scott Gottlieb to its ...

FDA's plan to boost cheaper copycat drugs could stall at the patent office

The FDA's push for lower-cost medicines looks good on paper, but the patent office under President Trump may be going in the ...
STAT

FDA’s stronger warning on Sarepta gene therapy raises new questions about heart risk

Risk of “acute, serious, and life-threatening” heart inflammation is now on the label of Sarepta's gene therapy for Duchenne ...

RFK Jr. Discussed Curbing FDA Head’s Role After Complaints About Management Style

Health Secretary Robert F. Kennedy Jr. considered installing a new leader to manage the agency on a day-to-day basis.

US FDA approves Arrowhead's genetic disorder drug

The U.S. Food and Drug Administration approved Arrowhead Pharmaceuticals' drug for a type of genetic disorder that causes ...

FDA Issues Warning to Over a Dozen Companies Selling Counterfeit Botox — Including Several in the U.S.

The FDA has issued warning letters to over a dozen companies selling 'unapproved' brands of Botox and warns consumers of the ...

FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year.
STAT

FDA clears spinal cord stimulator for home use

The FDA has cleared home use of a device that helps people with spinal cord injuries regain mobility and functioning.

Sarepta’s Elevidys to Remain on Market With New FDA Warning

Sarepta Therapeutics Inc.’s controversial gene therapy for a rare muscle condition will remain available in the US with a ...

Eminent Spine’s 3D Printed Titanium Posterior SI System Receives FDA 510(k) Clearance

Eminent Spine, a leader in spinal implant innovation, proudly announces that its revolutionary 3D Printed Titanium Posterior SI System has received FDA 510(k) clearance as of October 7, 2025.

FDA taps oncology expert Pazdur as nation’s top drug regulator

Richard Pazdur, a longtime Food and Drug Administration employee, would lead its center that oversees over-the-counter and ...