Tag: TRI FDA

EBGLYSS is now the only approved option that offers as few as six maintenance injections per year with no required topicals from the startINDIANAPOLIS,...

Ethics Committee Approval Received for Pivotal Study Intended to Support U.S. FDA Class II Submission for QuickScan™ Strep AVANCOUVER, BC, June 4, 2026 /CNW/...

Modeyso is the first treatment option for this ultra-rare and aggressive brain tumor, which primarily affects children and young adults Accelerated approval based on an...

OSLO, Norway, Aug. 5, 2025 /PRNewswire/ -- Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, today announced that the U.S....

SAN FRANCISCO and SUZHOU, China, Aug. 4, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality...

First modules of BLA submitted to FDA under rolling review, with full submission anticipated in early 2026MCO-010 BLA for retinitis pigmentosa is eligible for priority review...

Orphan drug designation highlights the potential for ADRX-0405 to address the high unmet need in gastric cancerSAN DIEGO, July 8, 2025 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"),...

Congenital adrenal hyperplasia (CAH) is a rare autosomal recessive disease1 with an estimated global incidence of approximately 1 in 14,000–18,000 live births2A phase II...

Congenital adrenal hyperplasia (CAH) is a rare autosomal recessive disease1 with an estimated global incidence of approximately 1 in 14,000–18,000 live births2A phase II...

ANDEMBRY inhibits the top of the HAE cascade by targeting factor XIIa and provides sustained protection from attacksOnce-monthly dosing reduced HAE attacks by a...