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Drug Approval

Shilpa Medicare’s Nor UDCA Approved by SEC for NAFLD Treatment

Shilpa Medicare Limited , a leading API and formulation manufacturer, announces that the Subject Expert Committee (SEC) of CDSCO has approved it...

March 12, 2025 | News

Ascletis’ ASC47 Shows Promise as a Long-Acting, Muscle-Preserving Obesity Treatment in Phase Ib Study

ASC47, an adipose-targeted muscle-preserving weight loss drug candidate for the treatment of obesity, demonstrated a half-life of up to 26 days and ...

March 12, 2025 | News

Japan Grants Orphan Drug Designation to Lundbeck’s Amlenetug for Multiple System Atrophy

The Ministry of Health, Labor, and Welfare (MHLW) in Japan has granted Orphan Drug Designation (ODD) to Lundbeck's investigational drug, amlenetu...

March 11, 2025 | News

Sichuan Kelun-Biotech’s TROP2 ADC Sacituzumab Tirumotecan Secures NMPA Approval for EGFR-Mutant NSCLC

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company's trophoblast cell-surface antigen 2 (TROP...

March 11, 2025 | News

Fosun Pharma’s Foritinib Secures NMPA Nod for ALK+ NSCLC with Strong CNS Control and Improved Safety

Fosun Pharma announced that the National Medical Products Administration (NMPA) has officially accepted the marketing authorization application for Foritin...

March 10, 2025 | News

GenAssist Gains FDA IND Clearance for First-in-Class Base Editing Therapy for Duchenne Muscular Dystrophy

GenAssist Ltd (GenAssist), a pioneering gene-editing biotechnology company specializing in genome medicines, is thrilled to announce that it has received&n...

March 07, 2025 | News

ACG Leads the Charge in Vegan Capsules: Innovation, Certification, and the Future of Sustainable Pharma

As the demand for plant-based and clean-label pharmaceutical solutions grows, ACG Capsules has positioned itself at the forefront of innovation with its ve...

March 06, 2025 | Interview

Celltrion Secures FDA Approval for STOBOCLO® and OSENVELT® as Biosimilars to PROLIA® and XGEVA®

STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA®&nbs...

March 05, 2025 | News

Avecho and Sandoz Ink 10-Year Deal for Australia’s First Pharmaceutical CBD Capsule for Insomnia

Avecho and Sandoz sign an exclusive ten-year development and license agreement ("Agreement") for Avecho's pharmaceutical cannabidiol capsule for insomnia...

March 04, 2025 | News

China Fapon Biopharma secures US FDA IND approval for FP008 a first-in-class immunocytokine for resistant solid tumors

Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, is pleased to announce that the U.S. Food and Drug Administr...

March 03, 2025 | News

Fosun Pharma Secures NMPA Approval for Tenapanor, Bringing New Hope to Dialysis Patients in China

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma; stock code: 600196.SH, 02196.HK) announced that its holding subsidiary, Shanghai Fosun Pharm...

February 27, 2025 | News

MicuRx’s MRX-4 and Contezolid Show Favorable Safety and Efficacy in Phase III Trial for Diabetic Foot Infections

Data Monitoring Committee (DMC) has completed the first safety and efficacy assessment of the global Phase III clinical trial, recommending continued pro...

February 26, 2025 | News

Telix’s Kidney Cancer Imaging Agent Gains FDA Priority Review, Eyes 2025 Launch

Telix Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for TLX25...

February 26, 2025 | News

Chime Biologics and Mabgeek Advance MG-K10 to U.S. Phase III Trials for Atopic Dermatitis and Asthma

Chime Biologics, a leading global CDMO that enables its partners' success in biologics, announced its continued collaboration with Mabgeek ...

February 24, 2025 | News

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