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

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 ...

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

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

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

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 ...

The government 'did not act contrary to the law' by requiring drugmakers to seek approval before implementing proposed new 340B rebate models, a federal judge ruled.

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

Novo Nordisk CEO Lars Fruergaard Jørgensen will step down amid market challenges and a clinical disappointment for CagriSema.

It's been 13 weeks since Aardvark Therapeutics' $94 million initial public offering on Feb. 13 in the bleakest streak for ...