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

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

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

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

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

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

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

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

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

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

Bristol Myers Squibb CEO Chris Boerner said America’s role as the global biopharma leader is at a 'pivot point' as the Trump ...

Datavant acquires Aetion in health data merger. Deal doubles life sciences team to 400. CEO Kyle Armbrester says company has ...