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
FDA Grants Orphan Drug and Rare Pediatric Disease Designations to Ifetroban for Duchenne Muscular Dystrophy Cardiomyopathy

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, announced  that the United States (U.S.) Food and D...

November 07, 2024 | Thursday | News
Ionis Pharmaceuticals Announces Phase 3 Study Design for ION582 in Angelman Syndrome Following FDA Alignment

 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced the pivotal Phase 3 study design following successful alignment with the U.S. Food and...

November 07, 2024 | Thursday | News
European Medicines Agency Approves Dupixent for Treating Eosinophilic Esophagitis in Children Aged 1-11

The European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Specifical...

November 07, 2024 | Thursday | News
Acadia Pharmaceuticals to Sell Rare Pediatric Disease Priority Review Voucher for $150 Million

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced that it entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority...

November 06, 2024 | Wednesday | News
Ionis Pharmaceuticals Announces FDA Acceptance of NDA for Donidalorsen, a Potential Prophylactic Treatment for Hereditary Angioedema

 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New ...

November 05, 2024 | Tuesday | News

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