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BioPharma Drug Approval

Australia's Telix Pharmaceuticals Secures MHRA Approval for Illuccix® Prostate Cancer Imaging Agent in the UK

Telix Pharmaceuticals Limited announces that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approve...

February 13, 2025 | News

Fresenius Kabi Launches Calcitonin Salmon Injection to Treat Bone Disorders and Hypercalcemia

Fresenius Kabi, an operating company of Fresenius, announced it has introduced Calcitonin Salmon Injection, USP Synthetic, a calcium regulator, for the tre...

February 11, 2025 | News

AbbVie Announces FDA Approval of EMBLAVEO™, a Groundbreaking Antibiotic for Complicated Intra-Abdominal Infections

AbbVie announced the U.S. Food and Drug Administration (FDA) approval of EMBLAVEO™ (aztreonam and avibactam), marking a pivotal step in the fight aga...

February 10, 2025 | News

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

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