The FDA has granted Fast Track designation to the investigational antibody-drug conjugate (ADC) SIM0505 for the treatment of women with platinum-resistant ovarian cancer. The designation adds SIM0505 ...

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 ...

Climb Bio on Tuesday said there are currently no FDA-approved treatments for pMN, which affects about 75,000 people in the U.S. and can lead to chronic or end-stage kidney disease, requiring dialysis ...

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 ...

FDA fast track designation supports development of pelareorep plus bevacizumab/FOLFIRI in 2L KRAS-mutant MSS mCRC, enabling more frequent regulatory engagement and potential accelerated pathways.

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, ...