Morning. Today, we discuss how Duchenne patients and their families are responding to the shelving of Sarepta Therapeutics’ ...

Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...

From softwares to implants, here are 10 spine products earning FDA nods since May 15. 1. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions.

Roche Holding AG’s gene therapy Elevidys failed to get the backing of European regulators, a blow to the Swiss drugmaker and to Sarepta Therapeutics Inc., the embattled US biotech that developed the ...

U.S. Food and Drug Administration Commissioner Marty Makary said he is focused on overhauling long-held standards and ...

There was a lot of excitement when Tepezza became the first drug approved for the treatment of thyroid eye disease in January ...

Food and Drug Administration Commissioner Marty Makary said in a recent interview he has no plans to change policies regarding the abortion pill mifepristone.

The strategic reprioritization comes after the company hit two major hurdles in the past year, including a clinical hold for ...

The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, which scientists say could help end the virus’ transmission.

The recall has been given a Class II classification, indicating there is a significant level of risk posed to consumers in ...

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

China's Sciwind Biosciences is in talks with a U.S. company interested in licensing its experimental weight-loss drug for ...