The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an ...

Ekterly’s road to approval was not a smooth one. Last month, the FDA informed KalVista it would not meet its PDUFA date due ...

Regeneron Pharmaceuticals has won FDA accelerated approval of its Lynozyfic treatment for certain patients with the blood ...

Oklahomans should not have to fight their health insurer for the right to breathe. Blue Cross Blue Shield must abandon this new policy.

WASHINGTON (AP) — Government advisers were split Thursday on whether drugmakers need to update their COVID-19 vaccines for next season, a decision overshadowed by confusion over a new Trump ...

The FDA has approved a new antibiotic that can treat uncomplicated urinary tract infections, or uUTIs. It’s the first new class of oral antibiotics for UTIs in almost 30 years, according to ...

FDA Gives Full OK to Novavax COVID Shot for High-Risk Groups MONDAY, May 19, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) has granted full approval to Novavax’s COVID-19 ...

Regeneron on Wednesday said the FDA green light covers Lynozyfic in adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a ...

Regeneron Gets Accelerated FDA OK of Lynozyfic for Blood Cancer Treatment Provided by Dow Jones Jul 2, 2025, 3:39:00 PM. By Colin Kellaher .