Smith+Nephew Expands CORI◊ Surgical System Portfolio with FDA-Cleared CORIOGRAPH Pre-Op Planning for Hip Arthroplasty

Latest expansion to the CORI◊ Surgical System portfolio provides a personalized solution for patients and surgeons Smith+Nephew (LSE:SN, NYSE:SNN),...

December 20, 2024 | Friday | News
European Commission Grants Orphan Medicinal Product Designation to Mitapivat for Sickle Cell Disease

Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases...

December 19, 2024 | Thursday | News
Regeneron’s EYLEA HD® Achieves Key Milestone in Phase 3 QUASAR Trial for Macular Edema Due to Retinal Vein Occlusion

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the primary endpoint was met in the Phase 3 QUASAR trial investigating EYLEA HD® (af...

December 18, 2024 | Wednesday | News
Merck Announces FDA Acceptance of BLA for Clesrovimab (MK-1654), Investigational Monoclonal Antibody for Infant RSV Prevention

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics L...

December 18, 2024 | Wednesday | News
Jaypirca® (Pirtobrutinib) Gains Approval in China for Relapsed or Refractory Mantle Cell Lymphoma

Jaypirca®, a highly selective kinase inhibitor, utilizes a novel non-covalent binding mechanism to re-establish BTK inhibition in mantle cell lymphoma ...

December 16, 2024 | Monday | News
Eli Lilly's Omvoh® (Mirikizumab) Receives Positive CHMP Opinion for Crohn’s Disease in the EU

Eli Lilly and Company (NYSE: LLY) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human ...

December 16, 2024 | Monday | News
Roche Announces European Approval of Vabysmo® Prefilled Syringe for Treatment of Major Retinal Diseases

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the European Medicines Agency has approved Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe ...

December 16, 2024 | Monday | News
Accropeutics' RIPK2 Inhibitor AC-101 Receives FDA Clearance for Phase II Trial in Ulcerative Colitis

Accropeutics Inc. (Accropeutics), a clinical-stage biotech company with a focus on molecular mechanisms of regulated cell death and related pathogenesis in...

December 16, 2024 | Monday | News
FDA Grants Fast Track Designation to Sanofi’s Combination Vaccines for Influenza and COVID-19 in Older Adults

The US Food and Drug Administration has granted Fast Track designation to two Sanofi combination vaccine candidates to prevent influenza and COVID-19 infec...

December 13, 2024 | Friday | News
Sanofi Advances First Non-mRNA Flu-COVID Combination Vaccines with FDA Fast Track Designation

First non-mRNA combination vaccine candidates that include two already licensed vaccines to prevent influenza and COVID-19 infections Two phase 1/2 cl...

December 11, 2024 | Wednesday | News
Pilatus Biosciences' PLT012 Receives Orphan Drug Designation for Liver and Intrahepatic Bile Duct Cancer

Pilatus Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its leading molecule, PLT0...

December 11, 2024 | Wednesday | News
Lilly’s Pirtobrutinib Shows Strong Efficacy in Phase 3 BRUIN CLL-321 Trial for BTK-Inhibitor Pre-Treated CLL/SLL Patients

Eli Lilly and Company (NYSE: LLY) announced results from the Phase 3 BRUIN CLL-321 trial evaluating pirtobrutinib, a non-covalent (reversible) Bruton'...

December 10, 2024 | Tuesday | News
AbbVie’s Tavapadon Demonstrates Strong Efficacy in Phase 3 TEMPO-2 Trial for Early Parkinson’s Disease

AbbVie (NYSE: ABBV) announced positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating investigational tavapadon as a flexible-dose monot...

December 10, 2024 | Tuesday | News
Merck's KEYTRUDA® Combined with LYNPARZA® Achieves Key Milestone in Phase 3 Trial for Advanced Ovarian Cancer

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the Phase 3 KEYLYNK-001 trial evaluating KEYTRUDA ® (...

December 10, 2024 | Tuesday | News

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