Affinia Therapeutics has received the US Food and Drug Administration (FDA) fast track designation (FTD) for AFTX-201, a ...

Johnson & Johnson has won U.S. Food and Drug Administration fast-track designation for its investigational nipocalimab drug in adults with systemic lupus erythematosus, a chronic autoimmune disease.

The milestone is being celebrated as a “huge moment” for rare disease drug development.

MoonLake Immunotherapeutics (NASDAQ:MLTX) ("MoonLake" or the "Company"), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announces that ...

FDA fast track covers ART6043 plus olaparib in PARP inhibitor–naïve gBRCAm, HER2-negative locally advanced/metastatic breast ...

TSRA-196 is designed to precisely correct the genetic mutation underlying AATD, with the goal of restoring production of functional alpha-1 antitrypsin (AAT) protein through a one-time, durable ...

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 ...

FDA granted fast track designation to AKY-1189 for adults with metastatic urothelial cancer after systemic therapy, aiming to ...

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 ...

・As per Reuters, both the drugs have multibillion-dollar potential. ・FDA expects Merck to submit its applications for Enlicitide in April and for Sac-TMT in October or November next year. ・Other drugs ...

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 ...