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The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...

Jaguar Health announced that its product, cofelemer delayed-release tablets (Canalevia-CA1; Jaguar Health), received approved ...

In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...

The FDA has approved obecabtagene autoleucel (Aucatzyl) to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The FDA has approved a new oral antibiotic to treat uncomplicated urinary tract infections. Orylnvah is a broad-spectrum oral penem antibiotic for women who have limited or no alternative ...

The U.S. Food and Drug Administration (FDA) approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ...

Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the ...

New hope could be on the horizon for ALS patients in the form of a "breakthrough" drug, researchers say. Neuvivo, a California biopharmaceutical company that develops therapies for ...

after the US Food and Drug Administration (FDA) approved a supplemental new drug application. The expanded approval for the oral suspension is for the treatment of sudden muscle weakness ...

The US Food and Drug Administration (FDA) has approved AbbVie's VYALEV (foscarbidopa and foslevodopa) to treat motor fluctuations in adults with advanced Parkinson's disease (PD). The chronic ...