FDA Approves ALYFTREK® (Vanzacaftor/Tezacaftor/Deutivacaftor) as Once-Daily Treatment for Cystic Fibrosis

 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved ALYFTREK (v...

December 21, 2024 | Saturday | News
FDA Approves Zepbound® (Tirzepatide) as First Treatment for Moderate-to-Severe Obstructive Sleep Apnea in Adults with Obesity

Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved Zepbound® (tirzepatide) as the fir...

December 21, 2024 | Saturday | News
FDA Approves BRAFTOVI® Combination Therapy for First-Line Treatment of Metastatic Colorectal Cancer with BRAF V600E Mutation

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuxi...

December 21, 2024 | Saturday | News
FDA Approves Ionis’ TRYNGOLZA™ as the First Treatment for Familial Chylomicronemia Syndrome (FCS)

 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has approved TRYNGOLZA™ (o...

December 20, 2024 | Friday | News
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

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