regulatory approval

Singapore | May 4, 2026 Specialised Therapeutics has announced that NIKTIMVO® (axatilimab) has received regulatory approval from the Therapeutic...

Toronto, Canada | May 1, 2026 Apotex has received Health Canada approval for Apo-Semaglutide Injection™, a generic equivalent of...

FOSTER CITY, Calif., April 17, 2026 Gilead Sciences, Inc. has announced that it has obtained all required regulatory approvals...

Madison, New Jersey, U.S. | April 15, 2026 LEO Pharma has announced that the U.S. Food and Drug Administration...

Rockville, Maryland, U.S. | April 15, 2026 Leadiant Biosciences has announced a major regulatory milestone with Health Canada approval...

WALTHAM, Massachusetts | April 9, 2026 Swedish Orphan Biovitrum (Sobi) has announced that Health Canada has approved EMPAVELI® (pegcetacoplan),...

MIRAMAR, Fla., April 9, 2026 DifGen Pharmaceuticals LLC, in collaboration with Apotex Inc., has announced that the U.S. Food...

SALT LAKE CITY, April 2, 2026 Co-Diagnostics, Inc. announced that its joint venture CoMira Diagnostics has received approval to...

LANGHORNE, Pa., March 30, 2026 Savara Inc. has achieved a major regulatory milestone as the European Medicines Agency (EMA)...

BOSTON, March 19, 2026 Rhythm Pharmaceuticals announced that the U.S. Food and Drug Administration has approved Imcivree (setmelanotide) for...