News

Did The FDA Make A Mistake? Sarepta's Elevidys Approval Under Scrutiny
FDA is investigating Sarepta's Elevidys after two deaths from liver failure in non-ambulatory DMD patients, raising safety ...
Fierce Pharma2d
FDA investigates patient deaths after treatment with Sarepta's Duchenne gene therapy Elevidys
In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, ...
BioSpace2d
FDA Reviews Sarepta’s Elevidys After Second Patient Death
The FDA is assessing the need for “further regulatory action” on Sarepta's Duchenne muscular dystrophy gene therapy in the ...
Stocktwits on MSN2d
Sarepta Stock Slumps After FDA Opens Probe Into Patient Death, Analyst Sounds Alarm
Brokerage H.C. Wainwright on Wednesday opined that there will be” little intrinsic value” in Sarepta Therapeutics (SRPT) if ...
FDA probes deaths of boys taking Sarepta Duchenne drug
The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne ...
STAT2d
Pharmalittle: We’re reading about FDA probing deaths after Sarepta treatment, a Regeneron plan for charities, and more
The FDA is investigating two deaths in non-ambulatory Duchenne muscular dystrophy patients who received a Sarepta gene ...
Sarepta Therapeutics (NasdaqGS:SRPT) Faces Shipment Suspension Amid Safety Update
Sarepta Therapeutics (NasdaqGS:SRPT) recently provided updates that may have influenced its stock performance. The announcement of a safety update for ELEVIDYS, concerning severe side effects and a ...
Sarepta Therapeutics' Elevidys Liver Deaths Trigger Selloff, A Contrarian Opportunity
Sarepta's stock drops on ELEVIDYS safety concerns, yet potential remains for ambulatory patients. Click here to read an ...
GlobalData on MSN4d
Sarepta and Roche halt DMD gene therapy’s use in certain patients after second death
Shares in both companies were down following news of the second death, casting fresh safety concerns over Elevidys.
STAT12d
Sarepta reports second patient death after treatment with Duchenne gene therapy
Sarepta said it was halting shipments of its Duchenne gene therapy for patients who can no longer walk, following the death ...
Managed Healthcare Executive11d
Sarepta Stops Shipments of Elevidys For Non-Ambulatory DMD Patients
A second patient with Duchenne muscular dystrophy has died from acute liver failure after receiving the gene therapy Elevidys ...
FDA investigates patient deaths after treatment with Sarepta's gene therapy
The U.S. Food and Drug Administration said on Tuesday that it is investigating reports of two deaths due to acute liver ...