PTC Therapeutics to Acquire ST-920 Fabry Gene Therapy Program
Warren, New Jersey, August 12, 2026 PTC Therapeutics announced that it was selected as the winning bidder to acquire...
regulatory approval
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Rhythm Pharmaceuticals Expands IMCIVREE Authorization in UK
Boston, Massachusetts, August 11, 2026 Rhythm Pharmaceuticals announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)...
Scholar Rock Advances Apitegromab FDA Review with Second Fill-Finish Facility
CAMBRIDGE, Mass., August 7, 2026 Scholar Rock announced that the U.S. Food and Drug Administration (FDA) review of its...
Allergan Aesthetics Secures FDA Review for BOTOX Cosmetic
Irvine, California, August 4, 2026 Allergan Aesthetics, an AbbVie company, has announced that the U.S. Food and Drug Administration...
Incyte Secures EU Approval for Opzelura Cream in Atopic Dermatitis
WILMINGTON, Del., July 29, 2026 Incyte announced that the European Commission (EC) has approved Opzelura® (ruxolitinib) cream for the...
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NewAmsterdam Pharma Wins CHMP Support for Ubeslo® and Evlarco®
NAARDEN, The Netherlands; MIAMI, USA; and FLORENCE, Italy, July 24, 2026 NewAmsterdam Pharma and its commercialization partner Menarini Group...
Acadia’s DAYBU Recommended for EU Approval in Rett Syndrome
SAN DIEGO, June 26, 2026 Acadia Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of...
Lilly Jaypirca CHMP Backs EU Approval for CLL Treatment
INDIANAPOLIS, June 26, 2026 Eli Lilly and Company announced that the European Medicines Agency’s Committee for Medicinal Products for...
FDA Authorizes Signati Medical’s Multi-Center Trial for Separo System
PROVIDENCE, Rhode Island, USA, June 2, 2026 Signati Medical has achieved a significant regulatory milestone after receiving U.S. Food...
Lupin Receives US FDA EIR for Ankleshwar Manufacturing Site
MUMBAI, India, May 28, 2026 Lupin Limited, one of the world’s leading pharmaceutical companies, has announced that it has...
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