Libtayo® Demonstrates Significant Improvement in Disease-Free Survival for High-Risk Cutaneous Squamous Cell Carcinoma in Phase 3 C-POST Trial

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced positive results from the Phase 3 C-POST trial, which demonstrated that adjuvant treatment wi...

January 14, 2025 | Tuesday | News
Bayer Submits Supplemental New Drug Application for KERENDIA® (Finerenone) to Treat Heart Failure with Preserved or Mildly Reduced Ejection Fraction

Bayer announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for KERENDIA® (finerenone...

January 13, 2025 | Monday | News
Revvity Secures FDA Clearance for EUROIMMUN’s Groundbreaking Free Testosterone Test

-Revvity, Inc.  announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN’s automated chemilu...

January 13, 2025 | Monday | News
Samsung Bioepis and Teva Forge Strategic Partnership for U.S. Launch of EPYSQLI® Biosimilar

Samsung Bioepis Co., Ltd. and Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) announced that the companies have entered into a license, developm...

January 13, 2025 | Monday | News
NextCure Doses First Patient in Phase 1 Study of LNCB74, a Promising Cancer Therapy

NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-c...

January 13, 2025 | Monday | News
Partner Therapeutics Partners with BARDA to Fund Phase 2 Study of LEUKINE in Sepsis Patients

Partner Therapeutics, Inc. (PTx) announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administrat...

January 10, 2025 | Friday | News
Grifols Submits Biologics License Application for New Fibrinogen Treatment to FDA

Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading manufacturer of plasma-derived medicines, announced it has submitted a B...

January 10, 2025 | Friday | News
Exelixis Announces FDA Update on sNDA for CABOMETYX® in Advanced pNET and epNET

 Exelixis, Inc. (Nasdaq: EXEL) announced it has been notified by the U.S. Food and Drug Administration (FDA) that the supplemental New ...

January 10, 2025 | Friday | News
FDA Accepts Revised sNDA for Astellas' IZERVAY™ in Treatment of Geographic Atrophy

 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced the U.S. Food and Drug Administration (FDA) a...

January 09, 2025 | Thursday | News
InkSpace Imaging Receives FDA Clearance for Next-Generation 1.5T 24-Channel MR Coil

InkSpace Imaging, a leader in MRI coil innovation, announced that the United States (US) Food and Drug Administration (FDA) has cleared InkSpace Imaging&rs...

January 09, 2025 | Thursday | News
Agios Pharmaceuticals Announces FDA Acceptance of Supplemental New Drug Application for PYRUKYND® in Thalassemia Treatment

Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases...

January 09, 2025 | Thursday | News
GSK Secures FDA Breakthrough Therapy Designation for GSK5764227 in Relapsed Osteosarcoma

GSK plc (LSE/NYSE: GSK) announced  that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for GSK5764227 (GSK&rsq...

January 08, 2025 | Wednesday | News
Norgine Files Marketing Authorization for Eflornithine in High-Risk Neuroblastoma with EMA

Norgine announced that it completed its marketing authorisation application filing to European Medicines Agency (EMA) for eflornithine in high-risk neurobl...

January 07, 2025 | Tuesday | News
LPOXY Therapeutics to Acquire Key Assets from Xeno Biosciences to Advance C. difficile Infection Prevention Therapy

LPOXY Therapeutics, Inc. ("LPOXY"), a clinical-stage biopharmaceutical company focused on innovative therapies for infectious disease prevention, announced...

January 06, 2025 | Monday | News

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