News

Sarepta drops as report suggests FDA needs new trials for Elevidys
Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...
Precision Medicine Online12h
Sarepta Halts Duchenne Gene Therapy Sales Amid FDA Scrutiny, Raising Concerns Over Financial Future
Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.
Sarepta Needs to Show FDA Elevidys Won’t Cause More Deaths
The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...
InnovationRx: Sarepta Blinks In Showdown With FDA
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
Sarepta pares gains as report suggests an ‘arduous’ path for Duchenne drug
Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to ...
FDA Inspectors Again Find Dangerous Breakdowns at an Indian Factory Supplying Medications to U.S. Consumers
The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even ...
Newsweek14d
Seed Recall Update as FDA Issues Highest Risk Warning
The Whole Herb Company Inc. issued a voluntary recall for select lots of its organic whole celery seeds on May 27 due to potential salmonella contamination.
Medscape15d
FDA Issues Early Alert for Medtronic pH-Monitoring Capsules
The US Food and Drug Administration (FDA) has issued an early alert for three Medtronic pH-monitoring capsule devices. The notice follows two letters sent in June to customers by the devices ...
Healthline17d
Blueberry Recall: FDA Issues Highest-Level Risk Warning for Listeria
The FDA issued its highest-level risk warning for a recent voluntary recall of hundreds of boxes of organic blueberries manufactured in Georgia by Alma Pak International over possible listeria ...
Austin American-Statesman22d
FDA issues Class I recall for blueberries due to listeria risk
Alma Pak International has issued a voluntary recall of bulk organic blueberries, affecting 400 boxes, each containing 30 pounds of the fruit.