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BioPharma Drug Approval

Astellas Pharma Announces NMPA Approval of Zolbetuximab in China for Advanced Gastric and GEJ Cancer

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the National Medical Products Administration (N...

January 06, 2025 | News

Everest Medicines Announces NEFECON® NRDL Implementation in China to Expand Access for IgAN Patients

Everest Medicines (HKEX 1952.HK, 'Everest', or the 'Company'), a biopharmaceutical company focused on the discovery, clinical development, manufacturing an...

January 06, 2025 | News

Japan Approves TEPOXX as First Antiviral Treatment for Orthopoxviruses, Including Smallpox, Mpox, and Cowpox

Regulatory decision marks first approval in Japan of an antiviral for the treatment of orthopoxviruses including smallpox, mpox and cowpox Japan Bi...

January 03, 2025 | News

Verastem Oncology’s NDA for Avutometinib-Defactinib Combo in KRAS Mutant LGSOC Accepted by FDA with Priority Review

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced that the U.S. Food a...

January 02, 2025 | News

Takeda’s HYQVIA Becomes First Facilitated Subcutaneous Immunoglobulin Approved in Japan for Immune Deficiency Disorders

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is the First and Only Facilitated Subcutaneous Immunoglobulin (f...

December 30, 2024 | News

Alphamab Oncology Receives NMPA Approval for Phase I/II Trial of Groundbreaking Subcutaneous Co-Formulation JSKN033

Alphamab Oncology (stock code: 9966.HK) announced that a phase I/II clinical trial (Study ID: JSKN033-102) of JSKN033, a high-concentration subcutaneous co...

December 27, 2024 | News

Keymed Biosciences Secures NMPA Approval for Stapokibart to Treat Chronic Rhinosinusitis with Nasal Polyposis

Keymed Biosciences Inc. announced the National Medical Products Administration (the "NMPA") of China has recently approved the supplemental New D...

December 24, 2024 | News

Vertex Announces FDA Approval of ALYFTREK™: A Once-Daily CFTR Modulator for Cystic Fibrosis Patients Aged 6 and Older

ALYFTREK™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not re...

December 23, 2024 | News

Innovent Biologics Secures NMPA Approval for DOVBLERON®, a Next-Generation Precision Therapy for ROS1-Positive NSCLC

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

December 23, 2024 | News

CStone Pharmaceuticals Submits Clinical Trial Application in Australia for CS2009, a Tri-Specific Antibody Targeting Solid Tumors

CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therap...

December 23, 2024 | News

Sanofi Acquires Greater China Rights for Aficamten from CORXEL, Expanding HCM Treatment Reach

Cytokinetics, Incorporated announced that Sanofi will acquire exclusive rights to develop and commercialize aficamten from Corxel Pharmaceuticals (CORXEL...

December 20, 2024 | News

Hong Kong DoH Approves AGAMREE® for Duchenne Muscular Dystrophy Treatment

Department of Health (DoH) of Hong Kong approved AGAMREE® for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older...

December 20, 2024 | News

Everest Medicines’ VELSIPITY® Prescribed in Mainland China, Pioneering New Ulcerative Colitis Treatment under Hong Kong-Macau Connect

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing an...

December 18, 2024 | News

Everest Medicines Announces First Prescription of VELSIPITY® for Ulcerative Colitis in Macau, Marking a Key Milestone in Asia

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing an...

December 13, 2024 | News

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