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FDA Advises Sarepta to Lift Pause and Resume ELEVIDYS Shipments for Ambulatory Duchenne Patients

Jul 30, 2025
Sarepta Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has informed the company it may lift its voluntary pause on shipments of ELEVIDYS (delandistrogene…
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Boehringer Ingelheim and Re-Vana Partner to Develop Long-Acting Eye Disease Therapies

Jul 30, 2025
Boehringer Ingelheim and Re-Vana Therapeutics, a US- and UK-based developer of ocular drug delivery technologies, have announced a strategic collaboration and licensing agreement aimed…
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GSK and Hengrui Pharma Partner to Develop Up to 12 Innovative Medicines in Key Therapeutic Areas

Jul 30, 2025
GSK plc has announced a major strategic collaboration with Hengrui Pharma, aimed at developing up to 12 innovative medicines across Respiratory, Immunology & Inflammation…
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FDA Approves SKYTROFA for Once-Weekly Adult Growth Hormone Deficiency Treatment

Jul 29, 2025
Ascendis Pharma A/S announced that the U.S. Food & Drug Administration (FDA) has approved SKYTROFA (lonapegsomatropin-tcgd) for the treatment of adults with growth hormone…
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Gilead’s Twice-Yearly Lenacapavir Gets Positive CHMP Opinion for HIV Prevention

Jul 28, 2025
Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending…
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EU Regulators Back Alhemo Label Expansion for Haemophilia A and B Without Inhibitors

Jul 25, 2025
Novo Nordisk announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an expanded label for Alhemo…
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Pfizer and BioNTech COVID-19 Vaccine Adapted for LP.8.1 Variant Receives Positive CHMP Opinion in EU

Jul 25, 2025
Pfizer Inc. and BioNTech SE announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending…
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Pfizer and 3SBio Finalize Licensing Deal

Jul 25, 2025
Pfizer Inc. has announced the completion of a global (excluding China) licensing agreement with Chinese biopharmaceutical company 3SBio Inc., securing exclusive rights to develop,…
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EU Approves Blenrep Combinations for Relapsed/Refractory Multiple Myeloma

Jul 24, 2025
GSK plc has announced that the European Union has approved its drug Blenrep (belantamab mafodotin) in combination therapies for the treatment of adults with relapsed or refractory…
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Solid Biosciences Earns FDA Fast Track for SGT-501 Gene Therapy in CPVT

Jul 24, 2025
Solid Biosciences Inc., a clinical-stage company focused on genetic medicines for neuromuscular and cardiac diseases, announced it has received Fast Track designation from the U.S. Food…
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