BioPharma Drug Approval
Shanghai Henlius and Organon Achieve FDA Approval for POHERDY, First Pertuzumab Biosimilar in the US
Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has approved the Biologics...
November 19, 2025 | News
Lundbeck Moves Closer to Asian Launch of Vyepti with New Drug Application Accepted in Japan
Lundbeck's new drug application (NDA) for Vyepti® (eptinezumab) accepted by Japan's Ministry of Health, Labor and Welfare (MHLW), mark...
November 17, 2025 | News
Lupin Launches Risperidone Long Acting Injectable in the United States with PrecisionSphere Technology
Global pharma major Lupin announced the launch of Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 5...
November 17, 2025 | News
EirGenix and Sandoz Sign USD 152 Million Global Deal for Pertuzumab Biosimilar
EirGenix Inc. announced that it has entered into a second global exclusive licensing agreement with international biosimilar leader Sandoz AG (SIX:SDZ/OTCQ...
November 13, 2025 | News
Mabwell Secures NMPA Approval to Begin Phase II Trial of First-in-Class Anti-IL-11 Antibody for Pathological Scarring
Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that its novel anti‑IL‑11 monoclonal antibody...
November 12, 2025 | News
Sanyou Bio and Yugong Bio Forge Strategic Alliance to Advance High-End Synthetic Molecular Enzymes
Sanyou Bio and Yugong Bio today announced the signing of a strategic cooperation agreement. This powerful alliance marks a significant step ...
November 12, 2025 | News
BioDlink and Lepu Biopharma Achieve China Approval for First-in-Class EGFR-Targeted ADC in Nasopharyngeal Carcinoma
BioDlink helps Lepu Biopharma win China's marketing approval for EGFR-targeted ADC treating recurrent or metastatic nasopharyngeal carcinoma T...
November 06, 2025 | News
Kazia Therapeutics Seeks FDA Guidance on Paxalisib Survival Data in Glioblastoma Under Project FrontRunner Framework
Kazia Therapeutics Limited ("Kazia" or the "Company")announced its intention to request and hold a follow-up Type C meeting with the U.S. Food & Drug A...
October 28, 2025 | News
Singapore Approves Pfizer-BioNTech’s LP.8.1-Adapted COVID-19 Vaccine for Individuals Aged Six Months and Older
The updated COVID-19 vaccine is expected to be available in Singapore at selected polyclinics and private general practitioner (GP) clinic...
October 27, 2025 | News
METiS TechBio’s AI-Designed MTS-004 Meets Phase III Success in China, Targeting Pseudobulbar Affect
MTS-004 Poised to Fill an Unmet Need in the Treatment of Pseudobulbar Affect (PBA) METiS TechBio, a global leader in AI-driven nanodelivery and formulatio...
October 24, 2025 | News
Alphamab Oncology and CSPC’s HER2-Targeting ADC JSKN003 Receives Breakthrough Therapy Designation in China for Advanced Colorectal Cancer
Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (Stock Code: 1093.HK) jointly announced that biparatopic HER2-targ...
October 21, 2025 | News
Jacobio Pharma Partners with Oceanpine Capital in RMB 200 Million Equity Deal for Cardiovascular Research Subsidiary
Jacobio Pharma announced that its subsidiary, Beijing Jacobio Pharmaceuticals Co., Ltd. ("Beijing Jacobio"), has entered into a Capital Increase and Equity...
October 16, 2025 | News
Everest Medicines Secures Dual IND Approvals for EVM14, Its First Internally Developed Therapeutic mRNA Cancer Vaccine
EVM14 becomes Everest Medicines' internally developed therapeutic mRNA cancer vaccine to receive IND approvals from both China's National Medic...
October 14, 2025 | News
Jenscare’s LuX-Valve Plus Approved for Use in Greater Bay Area Under Hong Kong-Macao Medicine and Equipment Connect
Jenscare Scientific Co., Ltd. ("Jenscare" or the "Company") (HKEX: 9877), an innovative medical device company with comprehensive structural heart disease ...
October 13, 2025 | News
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