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

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

Trump signs executive order on drug pricing via 'most favored nation' model, GSK acquires $1.2B MASH program, Bayer cuts 2,000 jobs, and first CRISPR therapy treats infant.

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 ...

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

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