Category Regulatory

Lymphoma ADC Market Outlook 2030: Pipeline, Patents, Prices & Clinical Trials

Global Lymphoma Antibody Drug Conjugates Market 2030: Pipeline, Patents, Prices, Approved Sales, and Clinical Trial Insights Lymphoma Antibody Drug Conjugates Market Opportunity, Patent, Price, Approved Drug Sales & Clinical Trials Insight 2030”, providing an in-depth analysis of the evolving landscape…

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HELIOS-B Phase 3: Vutrisiran Shows Fewer GI Events in ATTR-CM Patients

Alnylam Pharmaceuticals Reports HELIOS-B Phase 3 Findings: Vutrisiran Reduces Gastrointestinal Events in ATTR-CM Patients Alnylam Pharmaceuticals, Inc. , a global leader in RNA interference (RNAi) therapeutics, today unveiled new analyses from the HELIOS-B Phase 3 study evaluating AMVUTTRA® (vutrisiran). Vutrisiran…

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AOP Health

International Day of Older Persons: AOP Health Raises Awareness of the Hidden Burden of Venous Leg Ulcers

International Day of Older Persons: AOP Health Brings Urgent Attention to the Silent Burden of Venous Leg Ulcers Every year on October 1, the world observes the United Nations’ International Day of Older Persons, a moment dedicated to honoring the…

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Quince Therapeutics Publishes eDSP PopPK Modeling Study in CPT: PSP

Quince Therapeutics Publishes Advanced Population PK Modeling Study of eDSP in Pediatric Ataxia-Telangiectasia Patients in CPT: Pharmacometrics & Systems Pharmacology Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company pioneering patient-specific therapies for rare diseases, has announced the publication of…

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CHMP Recommends EU Approval of Koselugo for Plexiform Neurofibromas in Adults with Neurofibromatosis Type 1

Potential First Approved Treatment in the EU Targeting NF1-Associated Plexiform Neurofibromas koselugo (selumetinib), an oral, selective MEK inhibitor, has been recommended for approval in the European Union (EU) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with…

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CHMP Recommends EU Approval of Tezspire for Chronic Rhinosinusitis with Nasal Polyps

CHMP Recommends EU Approval of Tezspire for Chronic Rhinosinusitis with Nasal Polyps AstraZeneca and Amgen’s Tezspire (tezepelumab) has been recommended for approval in the European Union (EU) for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The Committee…

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EU Approves Biogen’s ZURZUVAE® as First Treatment for Postpartum Depression

Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE® (zuranolone) to treat post-partum…

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EU approves Novo Nordisk’s oral semaglutide—the first oral GLP-1 RA to cut cardiovascular risks

EU approves first oral GLP-1 RA to cut cardiovascular risk Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Rybelsus® (oral semaglutide) label to reflect the cardiovascular…

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