Drug Approval
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
Zai Lab’s KarXT NDA Accepted by China’s NMPA for Schizophrenia Treatment
Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the ...
January 20, 2025 | News
AstraZeneca and Daiichi Sankyo’s DATROWAY Secures First US Approval for HR-Positive, HER2-Negative Breast Cancer
First approval in the US for AstraZeneca and Daiichi Sankyo’s DATROWAY based on TROPION-Breast01 results showing 37% reduction in the risk of d...
January 20, 2025 | News
Innovent and ASK Pharm Secure NMPA Approval for Limertinib to Treat EGFR T790M-Mutated NSCLC
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality me...
January 17, 2025 | News
Innovent Biologics Secures Breakthrough Therapy Designation for IBI343 in Advanced Pancreatic Cancer
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality me...
January 16, 2025 | News
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