GE HealthCare to Deploy 300+ Advanced CT Scanners Across Indonesia Under Landmark SIHREN Program

300+ advanced CT scanners to be installed in public hospitals across 38 provinces by 2028, to support early diagnosis and treatment of non-communicab...

December 18, 2025 | Thursday | News
Vanda Targets Mid-2026 Approval With Imsidolimab BLA for Generalized Pustular Psoriasis

Vanda Pharmaceuticals Inc.  announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ims...

December 16, 2025 | Tuesday | News
RedHill Biopharma Highlights Opaganib as Potential Add-On Therapy for Venetoclax-Resistant CLL

Resistance to venetoclax (Venclexta® and Venclyxto®, Abbvie / Genentech), the $2.5 billion blockbuster Chronic Lymphocytic Leukemia (CL...

December 16, 2025 | Tuesday | News
Vaxxas Gains Regulatory Green Light to Manufacture HD-MAP for Clinical Trials

Australian biotechnology pioneer Vaxxas Pty Ltd, has been granted a licence by the Therapeutic Goods Administration (TGA) to manufacture the Company&rsqu...

December 16, 2025 | Tuesday | News
J&J’s AKEEGA Wins FDA Approval After Cutting Progression Risk by More Than Half in BRCA2-Mutated mCSPC

Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for AKEEGA® (n...

December 15, 2025 | Monday | News
Savara Secures Key European Patent for MOLBREEVI as It Prepares Global Regulatory Filings

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the EPO notified the...

December 12, 2025 | Friday | News
SOLVD Health Launches Studies To Validate GLP 1 Patient Stratification Diagnostic Platform

SOLVD Health, a patient intelligence company developing cutting-edge precision solutions to deliver better health outcomes, announced the launch of two s...

December 10, 2025 | Wednesday | News
SS Innovations Submits 510(k) Application to FDA for SSi Mantra Surgical Robotic System

SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic...

December 09, 2025 | Tuesday | News
Resmed Receives FDA Clearance for Smart Comfort, the First AI-Enabled Tool for Personalized CPAP Therapy Settings

Resmed , the leading health technology company focused on sleep, breathing and care delivered in the home, announced it has received U.S. Food and Drug A...

December 09, 2025 | Tuesday | News
Pfizer Phase 3 BASIS Study Shows HYMPAVZI Delivers 93% Bleed Reduction in Hemophilia With Inhibitors

-Pfizer Inc. (NYSE: PFE) today presented results from the Phase 3 BASIS study (NCT03938792) evaluating HYMPAVZI® (marstacimab) for adults and adolesc...

December 08, 2025 | Monday | News
Bayer Initiates Phase IIa ASSESS Trial of Investigational Antibody BAY 3401016 for Alport Syndrome

BAY 3401016 is an investigational monoclonal antibody with potential to block a protein called Semaphorin 3A (Sema3A), which is thought to be involve...

December 05, 2025 | Friday | News
Taiho Oncology Europe Announces UK Launch of Lytgobi (Futibatinib) for Eligible Patients With Locally Advanced or Metastatic Cholangiocarcinoma

Taiho Oncology Europe GmbH announced the UK launch of Lytgobi® (futibatinib), an irreversibly binding fibroblast growth factor receptor (FGFR) inhibi...

December 04, 2025 | Thursday | News
VANUDIS Implements Cenevo Labguru to Scale Operations and Strengthen Regulatory Readiness

VANUDIS, a biotechnology startup developing the next generation of antibody-based therapeutics, has implemented Cenevo’s Labguru solution to scale ...

December 04, 2025 | Thursday | News
Eisai and Biogen Submit Subcutaneous Lecanemab (LEQEMBI®) Application to Japan’s PMDA

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

December 01, 2025 | Monday | News

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