Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug Administration that it could resume shipping a drug it paused sales of last week.

Despite all the buzz around Sarepta and concerns about Elevidys, industry watchers aren’t convinced this current controversy ...

On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...

Sarepta Therapeutics'SRPT brutal week continued Friday after European officials rejected the company's controversial gene therapy, Elevidys.The rejection, which was delivered to European partner ...

Sarepta Therapeutics Inc. shares plunged after European regulators rejected its gene therapy Elevidys, intensifying scrutiny on the drugmaker after it was pressured to halt shipments of its treatment ...

Sarepta Therapeutics Inc. (NASDAQ:SRPT) stock declined 13% Friday after European regulators recommended against approving Elevidys, the company’s gene therapy for Duchenne muscular dystrophy.

The Company announced it was suspending shipments of ELEVIDYS for non-ambulatory patients while Sarepta took time to evaluate trial regimens and discussed findings with regulatory authorities.

Towards the end of June, Sarepta Therapeutics started facing a temporary suspension of shipments for ELEVIDYS, which is its gene therapy for Duchenne muscular dystrophy/DMD, specifically for non ...

Government Accountability Office GAO denies protest by challenging Navy rejection of protester late-submitted proposal in La Playa, Inc. of Virginia – d/b/a LPI Tech ...

California lawmakers are advancing a bill that would ease some of the nation’s strictest pharmacy staffing limits, allowing pharmacists to supervise more technicians at once. Under Assembly Bill ...

The manufacturing-related rejection also delays a key test of the new FDA leadership’s support for cell and gene therapy against rare diseases.