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
Mexico Approves Eisai and Biogen’s LEQEMBI for Early Alzheimer’s Disease Treatment

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusett...

December 09, 2024 | Monday | News
AstraZeneca’s Imfinzi Gains FDA Approval for Limited-Stage Small Cell Lung Cancer, Offering New Hope for Patients

AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cance...

December 09, 2024 | Monday | News
Zepbound® (Tirzepatide) Outperforms Wegovy® (Semaglutide) in Phase 3b SURMOUNT-5 Trial, Demonstrating Superior Weight Loss

Eli Lilly and Company (NYSE: LLY) announced topline results from the SURMOUNT-5 phase 3b open-label randomized clinical trial. Zepbound® ...

December 09, 2024 | Monday | News
FDA Accepts Roche's Supplemental Biologics License Application for Columvi® in Combination with GemOx for Relapsed or Refractory DLBCL

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics Licen...

December 09, 2024 | Monday | News
Dewpoint Therapeutics and Mitsubishi Tanabe Pharma Partner to Advance Groundbreaking ALS Therapy

- Both companies will collaborate to advance a small molecule condensate modulator targeting TDP-43, with the potential to address the underlying patholo...

December 05, 2024 | Thursday | News

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