Fast Track status enables closer FDA engagement to potentially accelerate development of a CDH6-directed ADC in ...

KT-621 BREADTH Phase 2b asthma trial ongoing, with data expected to be reported in late 2027 KT-621 BROADEN2 Phase 2b atopic dermatitis (AD) trial ongoing, with data expected by mid-2027 Fast Track ...

Budoprutug receives FDA Fast Track status for primary membranous nephropathy after phase 1b data demonstrate clinical activity and safety.

The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by ...

STAT6 degradation is expected to provide a clinical benefit for patients with Type 2 inflammatory diseases, including asthma.

The FDA has granted fast track and rolling review status to Celltrion’s CT-P71, a Nectin-4 targeting ADC for treating ...

MELBOURNE, Australia and NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, announces ...

The U.S. Food and Drug Administration (FDA) has approved a once-daily GLP-1 pill for weight loss called orforglipron, and ...

NASHVILLE, Tenn., Feb. 4, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on developing new products for rare diseases, announced today ...

Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29 ...

With Fast Track designation, we believe this can support the acceleration of our Phase 3 program through earlier and more frequent FDA engagement, enabling faster addressing of development questions, ...