Novartis Announces European Commission Approval of Kisqali® (ribociclib) for Adjuvant Treatment of High-Risk HR+/HER2- Early Breast Cancer

Novartis announced that the European Commission (EC) has approved Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) for the ad...

November 28, 2024 | Thursday | News
Alnylam's Vutrisiran sNDA Accepted by FDA for Priority Review in ATTR-CM with March 2025 Decision Expected

 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced that the U.S. Food and Drug Administration&n...

November 26, 2024 | Tuesday | News
GSK’s Blenrep Combination Therapy Accepted for FDA Review in Relapsed Multiple Myeloma

GSK plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep&...

November 26, 2024 | Tuesday | News
MSD Announces Positive Phase 3 ZENITH Study Results for WINREVAIR in Pulmonary Arterial Hypertension

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced positive topline results from the Phase 3 ZENITH study evaluating WINREV...

November 26, 2024 | Tuesday | News
West China Lecheng Hospital Launches Vorasidenib, First-in-Class Targeted Therapy for IDH-Mutant Glioma

It was announced that West China Lecheng Hospital has successfully introduced Vorasidenib for treatment at clinical practices, and the treatment began at o...

November 25, 2024 | Monday | News
Hanmi Pharmaceutical Showcases Promising Clinical Progress of BH3120 at SITC 2024 Conference

The latest progress in the clinical trial of BH3120, an innovative immunotherapy jointly developed by Hanmi Pharmaceutical and Beijing Hanmi Pharmaceutical...

November 25, 2024 | Monday | News
Zevra Therapeutics Launches MIPLYFFA™, the First FDA-Approved Treatment for Niemann-Pick Disease Type C

MIPLYFFA, the first FDA-approved treatment for Niemann-Pick disease type C, is available at Zevra’s specialty pharmacy for dispense AmplifyAssist&...

November 22, 2024 | Friday | News
Kedrion Biopharma's Bolognana Facility FDA-Approved to Manufacture RYPLAZIM® for PLGD-1 Treatment

 Kedrion Biopharma Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the company's manufacturing facility in B...

November 22, 2024 | Friday | News
Jazz Pharmaceuticals Secures FDA Approval for Ziihera, First Dual HER2-Targeted Therapy for Advanced Biliary Tract Cancer

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera® (zan...

November 21, 2024 | Thursday | News
Tirzepatide Significantly Reduces Heart Failure Risk in Obese Patients with Preserved Ejection Fraction, New Data Show

Eli Lilly and Company (NYSE: LLY) announced detailed results from the SUMMIT Phase 3 trial showing tirzepatide significantly reduced the risk of worsening ...

November 18, 2024 | Monday | News
FDA Accepts Resubmission for Dupixent to Treat Chronic Spontaneous Urticaria (CSU)

The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (d...

November 18, 2024 | Monday | News
TrakCel's OCELLOS Platform Chosen to Support Five Key Cell Therapy Products in 2024, Streamlining CGT Supply Chain Management

TrakCel, a provider of integrated cell and gene therapy (CGT) orchestration solutions for the precise management, control and tracking of CGTs has announce...

November 13, 2024 | Wednesday | News
Arcturus Therapeutics Receives FDA Green Light for Clinical Trial of sa-mRNA Vaccine Targeting Pandemic H5N1 Influenza

Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focus...

November 12, 2024 | Tuesday | News
ResQ Pharma Receives PDUFA Date for FDA Review of LipidRescue Kit for Life-Threatening Anesthetic Reactions

ResQ Pharma, Inc., a Chicago-based pharmaceutical company developing and commercializing innovative drug therapies, announced that it has received a P...

November 12, 2024 | Tuesday | News

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