MONDAY, June 24, 2024 -- The U.S. Food and Drug Administration has expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene...

Following the label expansion, AbbVie's (ABBV) Epkinly is the first bispecific antibody approved to treat relapsed/refractory (R/R) follicular...

Per argenx (ARGX), the label expansion to Vyvgart Hytrulo makes it the first FDA-approved medication with a novel mechanism of action to treat chronic...

Longboard (LBPH) gains 14% as the FDA grants the Breakthrough Therapy designation to its investigational epilepsy treatment candidate, bexicaserin,...

Longboard (LBPH) gains 14% as the FDA grants the Breakthrough Therapy designation to its investigational epilepsy treatment candidate, bexicaserin,...

June 24, 2024 -- The U.S. Food and Drug Administration (FDA) has approved PiaSky (crovalimab-akkz) for the treatment of adult and pediatric patients...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 20, 2024-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare...

Roche announced that the European Medicines Agency (EMA) has validated and initiated review of the marketing authorisation application (MAA) for...

On June 12, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and...

FRIDAY, June 21, 2024 -- The U.S. Food and Drug Administration has expanded indications for Rinvoq (upadacitinib) to now include pediatric patients...