Kowa Gains FDA Breakthrough Status for K-808 in PBC
NAGOYA, Japan, June 30, 2026 Kowa Company, Ltd. has achieved a significant regulatory milestone after the U.S. Food and...
FDA Breakthrough Therapy Designation
Advertisement
Calico Wins FDA Breakthrough Status for Fosigotifator
SOUTH SAN FRANCISCO, Calif. | June 23, 2026 Calico Life Sciences has announced that the U.S. Food and Drug...
Vertanical’s Exilby Wins First European Approval for Chronic Pain
GRÄFELFING, Germany – June 9, 2026 VERTANICAL has achieved a major milestone in chronic pain treatment after receiving Germany’s...
Citius Oncology Reports Promising LYMPHIR Cancer Data
CRANFORD, N.J., June 1, 2026 Citius Oncology has announced encouraging Phase 1 clinical findings evaluating LYMPHIR® (denileukin diftitox-cxdl) in...
Servier’s Emi-Le Shows Promise in Rare ACC Cancer Trial
BOSTON, June 1, 2026 Servier has announced encouraging new clinical findings for Emiltatug Ledadotin (Emi-Le), an investigational B7-H4-targeted antibody-drug...
Advertisements
Merck’s Calderasib Earns FDA Breakthrough Therapy Status
RAHWAY, N.J., May 29, 2026 Merck (known as MSD outside the United States and Canada) has announced that the...
Bayer PET Tracer Shows Promise in Amyloidosis Study
BERLIN, Germany / WHIPPANY, N.J., May 7, 2026 Bayer announced positive topline results from the pivotal Phase III REVEAL...
FDA Grants Breakthrough Status to Sutacimig Therapy
CAMBRIDGE, Massachusetts, USA & COPENHAGEN, Denmark — March 5, 2026 Hemab Therapeutics, a clinical-stage biotechnology company focused on developing...
FDA Breakthrough Status Advances Rett Syndrome Gene Therapy
DALLAS, Oct. 2, 2025 — The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to TSHA-102,...
NATCO Launches Generic Bosentan Tablets for Oral Suspension in the U.S. with 180-Day Exclusivity
Hyderabad, India, August 20, 2025 – NATCO Pharma Limited (BSE: 524816 and NSE: NATCOPHARM) today announced the launch of...
Advertisement
