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)...
regulatory milestone
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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...
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...
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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...
Adcendo Secures FDA Fast Track for ADCE-D01 Targeting Soft Tissue Sarcoma
COPENHAGEN, Denmark, Oct. 9, 2025 – (cGxP.wire) – Adcendo ApS, a biotechnology company pioneering first- and best-in-class antibody-drug conjugates...
Kedrion Biopharma Secures FDA Nod for QIVIGY® and Expands U.S. Growth Plan
September 29, 2025 – Kedrion Biopharma announced a major regulatory and strategic milestone with the U.S. Food and Drug...
Biocon Biologics Wins FDA Nod for Denosumab Biosimilars
BENGALURU, India & BRIDGEWATER, N.J. – September 17, 2025 –Biocon Biologics Ltd. (BBL), a global leader in biosimilars and...
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