Sarepta Therapeutics is meeting with the FDA in June to discuss expanding the use of its Duchenne muscular dystrophy gene ...

The government 'did not act contrary to the law' by requiring drugmakers to seek approval before implementing proposed new ...

The Trump administration is partnering with Mark Cuban’s compounding business and four other entities to improve the ...

Rocket Pharmaceuticals reports early success in gene therapy trial for heart condition PKP2-ACM, with 3 patients showing ...

American Society of Gene & Cell Therapy meeting sees 10% drop in attendance. Notable absences include FDA officials, David ...

The FDA is prepping to renegotiate its multibillion-dollar, quinquennial user fee agreements with the drug industry later ...

The US Supreme Court should decline to review a generic drug labeling fight between Amarin and Hikma Pharmaceuticals because ...

BioMarin plans to buy Boston-based Inozyme Pharma and its Phase 3 enzyme replacement therapy for about $270 million, the ...

FDA lifts hold on Scynexis' ibrexafungerp Phase 3 fungal infection trial, but GSK plans to end study. Incyte's Zynyz gets FDA ...

Leo Pharma is doing an extensive revamp of its leadership team as it splits product strategy and international operations ...

RFK Jr. advisor Calley Means challenges drugmakers considering pulling their investment in the US over Trump's most favored ...

A Delaware jury on Thursday said Regeneron should get more than $400 million in damages in its long-running antitrust case ...