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BioPharma Drug Approval

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

Australia Grants First Global Market Approval for YORVIPATH® to Treat Chronic Hypoparathyroidism

YORVIPATH® (palopegteriparatide) is now registered by the Therapeutic Goods Administration (TGA) for the treatment of chronic hypoparathyroidism...

February 21, 2025 | News

Ascletis’ ASC30 Oral Tablet Shows Promising Weight Loss in U.S. Phase Ib Obesity Trial

- ASC30 oral once-daily tablet demonstrated a 6.3% mean body weight reduction from baseline after 28-day treatment in multiple ascendi...

February 20, 2025 | News

Australia’s Clarity Pharmaceuticals Secures FDA Fast Track for 67Cu-SAR-bisPSMA in Prostate Cancer

Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation pr...

February 20, 2025 | News

VIVOZON’s UNAFRA Inj. Secures MFDS Approval as South Korea’s First First-in-Class Non-Opioid Analgesic

VIVOZON Pharmaceutical announced that its non-opioid analgesic, UNAFRA Inj., was approved on December 12, 2024. (active ingredient: Opiranserin H...

February 19, 2025 | News

TAHO Pharmaceuticals’ Apixaban Oral Dissolving Film Shows Positive Results in Pivotal Study

TAHO Pharmaceuticals announces positive preliminary results from the pivotal study of TAH3311, the world's first Apixaban oral dissolving film (ODF). The s...

February 18, 2025 | News

Kexing Biopharm Receives FDA Approval for Clinical Trials of GB05 Inhalation Therapy for Pediatric RSV Infections

Kexing Biopharm Co., Ltd. (Stock Code: 688136.SH) recently announced that the Investigational New Drug Application (IND) of GB05, Human Interferon α1...

February 17, 2025 | News

IASO Biotherapeutics’ New Drug Application for Equecabtagene Autoleucel Accepted by Hong Kong Department of Health

IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative ce...

February 17, 2025 | News

Innovent’s IBI363 Secures Second FDA Fast Track Designation for Advanced Lung Cancer

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality m...

February 17, 2025 | News

Akeso Receives IND Approval in China for AK139, the First IL-4Rα/ST2 Bispecific Antibody

Akeso, Inc. is pleased to announce the acceptance of its Investigational New Drug (IND) application by the China National Medical Products Administration (...

February 14, 2025 | News

XPOVIO® Secures Approval in Taiwan as First XPO1 Inhibitor for Relapsed/Refractory Multiple Myeloma

XPOVIO® is the first XPO1 inhibitor approved in Taiwan for the treatment of adult patients with relapsed/refractory multiple...

February 14, 2025 | News

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