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Drug Approval

Keymed Biosciences Gains NMPA Approval for Stapokibart in Treating Seasonal Allergic Rhinitis

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

February 10, 2025 | News

Nuance Pharma Secures First Regulatory Approval for Ohtuvayre™ in Macau for COPD Treatment

Nuance Pharma ("Nuance") announced that the Pharmaceutical Administration Bureau Macau approved Ohtuvayre™ (ensifentrine) for the maintenance tr...

February 07, 2025 | News

Harbour BioMed Secures NMPA Approval for HBM9378/SKB378 and Signs $970M Global Licensing Deal

Harbour BioMed (HKEX: 02142, the "Company"), a global biopharmaceutical company committed to the discovery, development and commercialization of novel anti...

February 06, 2025 | News

Henlius Secures EU Approval for Serplulimab Expanding Global Cancer Care

Shanghai Henlius Biotech, Inc. (2696.HK) has secured a significant milestone with the European Commission (EC) approval of HANSIZHUANG (serplulimab...

February 06, 2025 | News

Merck’s CAPVAXIVE Recommended for EU Approval to Prevent Pneumococcal Disease in Adults

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the Eu...

February 03, 2025 | News

Daiichi Sankyo & AstraZeneca’s Datopotamab Deruxtecan Recommended for EU Approval After Cutting Disease Progression Risk by 37%

Recommendation based on TROPION-Breast01 results showing Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan reduced risk of disease prog...

February 03, 2025 | News

China Approves Sarclisa as First Anti-CD38 Therapy for Newly Diagnosed Multiple Myeloma Patients

Sarclisa is the first anti-CD38 treatment approved in China for patients with newly diagnosed multiple myeloma ineligible for transplant A...

January 31, 2025 | News

Akeso Secures CDE Approval for IL-17 Monoclonal Antibody Gumokimab to Address Plaque Psoriasis

Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the New Drug Application (NDA) of its internally-developed IL-17-targeting mon...

January 27, 2025 | News

Kelun-Biotech Secures NMPA Approval for Tagitanlimab in First-Line Treatment of Nasopharyngeal Cancer

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company received marketing authorization in China from Natio...

January 24, 2025 | News

Akeso Inc. Receives Milestone Payment from Sichuan Kelun for PD-L1 Antibody Tagitanlimab After China’s Regulatory Approval

Akeso Inc. (9926.HK) announced that it had received payment from Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. ("Sichuan Kelun") for their coll...

January 23, 2025 | News

TAHO Pharmaceuticals Completes Pivotal Trial for World’s First Anticoagulant Oral Dissolving Film

TAHO Pharmaceuticals is pleased to announce the successful completion of the pivotal trial for TAH3311, the first anticoagulant oral dissolving film (ODF)....

January 22, 2025 | News

Junshi Biosciences Secures Australian Approval for Toripalimab, First Immuno-Oncology Treatment for Nasopharyngeal Carcinoma

Shanghai Junshi Biosciences Co., Ltd , a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercializati...

January 21, 2025 | News

Telix Receives Regulatory Nod for PSMA PET Imaging in Prostate Cancer Across 19 European Nations

Telix Pharmaceuticals Limited announces that it has received a positive decision on the Marketing Authorization Application (MAA) for its prostate ca...

January 20, 2025 | News

Innovent and ASK Pharm Secure NMPA Approval for Limertinib in EGFR T790M-Mutated NSCLC

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

January 20, 2025 | News

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