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.

Else Nutrition Announces Major Breakthrough: President Trump Signs Pivotal FDA Funding Package that Includes Congressional Directive Streamlining Regulatory Pathway for Non ...

ELSE NUTRITION HOLDINGS INC. (BABY) (BABYF) (0YL.F) ("Else" or the "Company"), a global pioneer in whole-food, plant-based nutrition for babies, toddlers, children and adults, today recognizes the ...

ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)US FDA ...

icotec Medical: icotec Receives FDA Clearance for the CMORE CT System, Expanding its BlackArmor Engineered Carbon/PEEK Technology to the Posterior Cervicothoracic Spine

ALTSTÄTTEN, Switzerland and BOSTON, Nov. 13, 2025 /PRNewswire/ -- icotec, the pioneer of implantable devices made from BlackArmor® Engineered Carbon/PEEK, today announced that the U.S.
Santé log

Emergent BioSolutions Marks 10-Year Anniversary of the U.S. FDA Approval of NARCAN® Nasal Spray and Reinforces its Commitment to Increasing Naloxone Access

About NARCAN® Nasal Spray NARCAN ® Naloxone HCl Nasal Spray 4 mg is the first FDA-approved, over-the-counter (OTC) 4 mg naloxone product for the emergency treatment of opioid overdose. NARCAN ® Nasal ...
Food Safety News

FDA increases import enforcement because of sulfites, Salmonella and more

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries.
Food Safety News

Congresswoman demands that FDA release all inspection reports on ByHeart infant formula production plants

A U.S. representative is pressing the FDA for information about ByHeart Inc., the company linked to an outbreak of infant ...

Arrowhead Pharmaceuticals Announces FDA Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS)

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has approved ...
GV Wire

RFK Jr. Discussed Scaling Back the Role of FDA Chief Makary, WSJ Reports

Explore the recent discussions involving RFK and FDA leadership changes under the Trump administration for better public ...

Penn, CHOP will test gene therapy for rare diseases with new FDA trial protocol

Penn and CHOP researchers want to develop urea cycle disorder treatments using CRISPR gene-editing therapy. Get unlimited access to Inquirer.com and The Inquirer App, plus 5 articles each month to ...
AARP

Federal Government Reopens, FDA Removes Hormone Therapy Warning

Take the memory test and earn double points thru 11/23/25 Help Register Login Login Hi, %{firstName}% Hi, %{firstName}% Games Car rental For the week of November 14, 2025: The federal government ...