Rhythm Gains Health Canada Approval for IMCIVREE in HO
BOSTON — September 22, 2026 Rhythm Pharmaceuticals announced that Health Canada has approved IMCIVREE® (setmelanotide) for weight management in...
regulatory approval
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Abeona Congratulates Ultragenyx on FAYUVI FDA Approval
CLEVELAND, Ohio — September 18, 2026 Abeona Therapeutics congratulated Ultragenyx Pharmaceutical on the U.S. FDA approval of FAYUVI™ (rebisufligene...
IMPACT Therapeutics Gains Positive CHMP Opinion for Senaparib
NANJING, China and BASILDON, UK — September 18, 2026 IMPACT Therapeutics and Pharmanovia announced that the Committee for Medicinal...
Novartis Advances Cosentyx for Polymyalgia Rheumatica
Basel, Switzerland, September 18, 2026 Novartis has announced that the European Medicines Agency’s Committee for Medicinal Products for Human...
LEO Pharma Gains FDA Priority Review for Dersimelagon
BALLERUP, Denmark — September 18, 2026 LEO Pharma announced that the U.S. Food and Drug Administration (FDA) has accepted...
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Novo Nordisk Gains Positive CHMP Opinion for FREHEMGO
BAGSVAERD, Denmark — September 17, 2026 Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP)...
LEO Pharma Gains Positive CHMP Opinion for Anzupgo
BALLERUP, Denmark — September 18, 2026 LEO Pharma announced that the European Medicines Agency’s Committee for Medicinal Products for...
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...
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...
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