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Drug Approval

Caliway Advances Global Phase 3 Programme For CBL 514 Following U.S. FDA IND Clearance

Asia-Pacific Phase 2 Study CBL-0206 Also Approved by Australia HREC and Taiwan TFDA, Accelerating Global Dual-Track Strategy ...

May 26, 2026 | News

Scribe Therapeutics Gains Australian Clearance To Begin First Human Trial Of STX 1150 For Hypercholesterolemia

Scribe Therapeutics, Inc. (Scribe), a clinical-stage biotechnology company engineering purpose-built in vivo CRISPR technologies designed to exte...

May 26, 2026 | News

Nuance Pharma Secures NMPA Clearance For Pivotal Actair® Allergy Trial In China

NMPA Approval Marks Key Milestone in Advancing House Dust Mite Allergy Immunotherapy to Chinese Patients Nuance Pharma announced that the National Medical...

May 25, 2026 | News

AbbVie Receives Positive CHMP Opinion For MAVIRET In Acute Hepatitis C Treatment

The positive opinion is supported by data from the Phase 3 M20-350 study evaluating the safety and efficacy of MAVIRET® in a...

May 25, 2026 | News

Lupin Limited Enters China Market With Approval For Paediatric Oseltamivir Oral Suspension

Global pharmaceutical company Lupin Limited announced that China's National Medical Products Administration has approved the shortened marketing authorizat...

May 25, 2026 | News

FUJIFILM Cellular Dynamics Opens New U.S. iPSC Manufacturing Hub To Expand Cell Therapy And Drug Discovery Capabilities

Site will serve as company’s new headquarters and expands capacity and capabilities for induced pluripotent stem cell development...

May 21, 2026 | News

FDA Approves First All Oral INQOVI Plus Venetoclax Regimen For Newly Diagnosed AML Patients Ineligible For Intensive Chemotherapy

Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved INQOVI (decitabine and ced...

May 15, 2026 | News

GenScript Biotech Launches TurboCHO Protein Expression Kit To Accelerate Antibody Discovery Workflows

New kit offers researchers and development teams a meaningful advance in expression speed and output GenScript Biotech Corporation announced the laun...

May 14, 2026 | News

Cordis Launches SELUTION SLR Drug Eluting Balloon In Japan For Peripheral Artery Disease

Cordis, a global leader in interventional cardiovascular technologies, today announces the launch and availability of the SELUTION SLR™ PTA Drug...

April 29, 2026 | News

Kyowa Kirin Co., Ltd. And Kura Oncology, Inc. Advance Ziftomenib With Japan Phase 2 Trial In NPM1 Mutated AML

Regulatory Filing in Japan Planned Following Clinical Trial Completion – Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) and Kura...

April 27, 2026 | News

ImmunoForge Advances CNS Drug Delivery With LMT15 Platform And Global Recognition

ImmunoForge's LMT15 Platform combines high BBB permeability with proprietary long-acting ELP technology Technology excellence validated by winning first...

April 23, 2026 | News

Biogen Inc. Secures Global Rights To Felzartamab Through Greater China Deal With TJ Biopharma

With this transaction, Biogen now owns exclusive worldwide development and commercialization rights to felzartamab, consolidating global rights under one...

April 22, 2026 | News

Mabwell Secures JFDA GMP Compliance For Denosumab Biosimilars, Marking PIC S Milestone

Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that its wholly-owned subsidiary, T-m...

April 22, 2026 | News

Orthogon Therapeutics Secures 11 Million Dollars To Advance First In Class Oral Therapy For BK Virus In Transplant Patients

Orthogon Therapeutics announced the closing of an $11 million follow-on financing, bringing the total capital raised to $36 million. The financing will ena...

April 21, 2026 | News

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