Roche Holding AG said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside ...

Savara faces an FDA setback for Molbreevi, its aPAP treatment. Learn how the company plans to recover and file a new BLA by ...

Lexi Homberger — a third grade teacher at Dodge Elementary — was recognized in 2023, by the Williamsville School Board, after ...

Experts say there’s no evidence GLP-1s can be absorbed through the skin — and these patches don’t contain the FDA-approved ...

George Tidmarsh, a Stanford University physician who founded Horizon Pharma and later ran La Jolla Pharma, was named head of ...

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

Replimune stock cratered Tuesday after the Food and Drug Administration unexpectedly rejected its experimental melanoma ...

The measure provides $27.1 billion to agencies including the USDA and FDA to invest in America’s rural communities, support ...

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...

This latest approval builds on an earlier liquid formulation of generic methimazole for feline hyperthyroidism, which ...

A functional precision medicine platform intends to streamline cancer treatment by matching patients against a battery of FDA ...

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.