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 ...

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

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

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

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 ...