Grünenthal Receives Dual FDA Designations for Tegacorat in DMD
AACHEN, Germany, July 8, 2026 Grünenthal has announced that the U.S. Food and Drug Administration (FDA) has granted both...
regulatory milestone
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SK Life Science NDA for Cenobamate Suspension Accepted
PARAMUS, N.J., June 15, 2026 SK Life Science, Inc. has announced that the U.S. Food and Drug Administration (FDA)...
Kashiv BioSciences Moves Closer to Launching XOLAIR Biosimilar in Canada
PISCATAWAY, N.J., June 4, 2026 Kashiv BioSciences has announced a significant regulatory milestone with the validation and acceptance by...
Pharming’s Joenja Wins CHMP Nod for APDS in EU
LEIDEN, Netherlands, March 27, 2026 Pharming Group N.V. announced that the Committee for Medicinal Products for Human Use (CHMP)...
CHMP Endorses Monthly Elfabrio Dosing for Fabry Disease
PARMA, Italy and CARMIEL, Israel, Jan. 30, 2026 — Chiesi Global Rare Diseases and Protalix BioTherapeutics announced that the...
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FDA Approves NEREUS™, First New Motion Sickness Drug in 40 Years
Washington, D.C. | December 30, 2025 — Vanda Pharmaceuticals Inc. has announced U.S. Food and Drug Administration (FDA) approval...
FDA Approves Addyi® for Postmenopausal Women With HSDD
RALEIGH, North Carolina — December 15, 2025 — Sprout Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA)...
Health Canada OKs Sephience™ for Phenylketonuria (PKU)
TORONTO, Dec. 10, 2025 — Health Canada has granted regulatory approval to Sephience™ (sepiapterin), an oral therapy developed by...
DAWNZERA Wins CHMP Backing for Preventing Hereditary Angioedema Attacks
Carlsbad, California, 14 November 2025 – Ionis Pharmaceuticals, Inc. and Otsuka Pharmaceutical Co., Ltd. announced that the Committee for...
Stealth BioTherapeutics Expands Access with Mito Assist™ and AnovoRx Partnership
NEEDHAM, Mass., October 9, 2025 — Stealth BioTherapeutics Inc. has announced the launch of Mito Assist™, a comprehensive patient...
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