The FDA has designated the viral vector rAAVrh74, which Sarepta Therapeutics, Inc. (NASDAQ:SRPT) uses in its gene therapy candidate SRP-9003 for limb-girdle muscular dystrophy type 2E/R4 (LGMD2E ...

(RTTNews) - Sarepta Therapeutics (SRPT), Wednesday announced that the FDA has designated its rAAVrh74 viral vector used in the investigational gene therapy SRP-9003 for limb-girdle muscular ...

May 27 (Reuters) - The U.S. FDA has paused Rocket Pharmaceuticals' (RCKT.O), opens new tab mid-stage gene therapy trial after a patient died from serious complications, the drug developer said on ...

ZL-1310 earns fast track designation in extensive-stage small cell lung cancer after early trial data showed tumor shrinkage in most patients treated. The United States Food and Drug Administration ...

The FDA is stepping up its unannounced inspections of foreign manufacturing facilities. In a statement about the increase in inspections, the Food and Drug Administration did not report how many ...

Former FDA leaders and employees have said the firings have compromised the agency’s ability to keep the country’s food safe. Also scheduled to be rehired are some of the 100 staff members who ...

The potential disruptions to FDA’s already strained inspection force are so great that agency leaders recently expedited plans to hire outside contractors to replace some fired workers ...

The U.S. Food and Drug Administration recently authorized the marketing of 20 nicotine pouch products under the Zyn brand, including flavors like Wintergreen and the "unflavored" Chill. That ...

The Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) for adults with limited-stage small cell lung cancer (SCLC) whose disease did not progress after concurrent platinum-based ...

ARS Pharmaceuticals (SPRY) announced that the FDA has approved neffy 1 mg for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and ...

"Highly sweetened" yogurts and cereals however can no longer be qualified as healthy, the FDA says. Your "healthy" yogurt may be getting a rebrand soon. On Thursday, the US Food and Drug ...

The FDA approved ensartinib for the treatment of certain patients with ALK-positive locally advanced or metastatic non-small cell lung cancer. The indication applies to use of the agent for adults ...