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

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

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.

Johnson & Johnson JNJ announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its ...

Vusolimogene oderparepvec is a genetically modified herpes simplex type 1 virus designed to directly destroy tumors and generate an anti-tumor immune response.

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the ...

The Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 10-1 against the approval of brexpiprazole in combination with sertraline for the treatment of adults ...