AbbVie Receives FDA Approval for VYALEV™: First Continuous Subcutaneous Infusion Therapy for Advanced Parkinson's Disease

AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has approved VYALEV™ (foscarbidopa and foslevodopa) as the first and o...

October 18, 2024 | Friday | News
Alnylam Pharmaceuticals Submits Type II Variation for Vutrisiran to Treat ATTR Amyloidosis with Cardiomyopathy

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNA interference (RNAi) therapeutics company, announced the submission of a Type II Variatio...

October 17, 2024 | Thursday | News
Jazz Pharmaceuticals Reports Positive Phase 3 Results for Zepzelca® Combined with Atezolizumab in Small Cell Lung Cancer

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced positive top-line results from the Phase 3 clinical trial evaluating Zepzelca® (lurbinected...

October 16, 2024 | Wednesday | News
Sandoz Launches First FDA-Approved Generic Paclitaxel for Metastatic Breast Cancer

First FDA-approved abbreviated new drug application (ANDA) to reference medicine Single-dose 100 mg vial for intravenous use, approved for metastatic ...

October 14, 2024 | Monday | News
Aileron Therapeutics Showcases Promising LTI-03 Results for Idiopathic Pulmonary Fibrosis at ICLAF

Aileron Therapeutics,  a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs i...

October 14, 2024 | Monday | News
Pfizer Receives FDA Approval for HYMPAVZI™: A New Treatment for Hemophilia A and B

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis ...

October 14, 2024 | Monday | News
Burning Rock and Dizal Announce First NGS-Based Lung Cancer Diagnostic Approval by China’s NMPA

Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), an innovative company in the field of precision onco...

October 11, 2024 | Friday | News
Recipharm and Exela Pharma Forge Strategic Alliance to Boost U.S. Sterile Manufacturing with 100+ Million Units Capacity

Sterile manufacturing capability in the US with over 100 million readily-available units (including vials and Pre-Filled Syringes – PFS) Extensi...

October 04, 2024 | Friday | News
Oncocyte's GraftAssure™ Assay Adopted by Top U.S. and German Transplant Hospitals, Progresses Toward FDA Submission

GraftAssure™ research assay adopted by two research hospitals that are top-five-in-country by organ transplant volume Company clears first stage...

October 03, 2024 | Thursday | News
European Commission Approves Junshi Biosciences' Toripalimab for Two Key Cancer Indications

Shanghai Junshi Biosciences , a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of nov...

September 25, 2024 | Wednesday | News
Nxera Pharma Secures Japanese Approval for QUVIVIQ™ to Treat Insomnia Based on Positive Phase 3 Trial Results

The approval of QUVIVIQ™, a novel dual orexin receptor antagonist, is based on robust clinical efficacy and safety data, including from a Phase 3...

September 24, 2024 | Tuesday | News
Takeda Receives Japanese Approval for FRUZAQLA® (Fruquintinib) in Metastatic Colorectal Cancer Treatment

— Approval based on results from global Phase III FRESCO-2 trial in patients with previously treated metastatic colorectal cancer — &md...

September 24, 2024 | Tuesday | News
EMA's CHMP Recommends Approval of Intas Pharmaceuticals' HETRONIFLY® (Serplulimab) for Extensive-Stage Small Cell Lung Cancer

Intas Pharmaceuticals announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive op...

September 23, 2024 | Monday | News
AbbVie’s Mirvetuximab Soravtansine Receives Positive CHMP Recommendation for Platinum-Resistant Ovarian Cancer Treatment in EU

AbbVie announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommen...

September 23, 2024 | Monday | News

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