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Drug Approval

Kexing Biopharm Receives FDA Approval for Clinical Trials of GB05 Inhalation Therapy for Pediatric RSV Infections

Kexing Biopharm Co., Ltd. (Stock Code: 688136.SH) recently announced that the Investigational New Drug Application (IND) of GB05, Human Interferon α1...

February 17, 2025 | News

IASO Biotherapeutics’ New Drug Application for Equecabtagene Autoleucel Accepted by Hong Kong Department of Health

IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative ce...

February 17, 2025 | News

Innovent’s IBI363 Secures Second FDA Fast Track Designation for Advanced Lung Cancer

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

February 17, 2025 | News

Akeso Receives IND Approval in China for AK139, the First IL-4Rα/ST2 Bispecific Antibody

Akeso, Inc. is pleased to announce the acceptance of its Investigational New Drug (IND) application by the China National Medical Products Administration (...

February 14, 2025 | News

XPOVIO® Secures Approval in Taiwan as First XPO1 Inhibitor for Relapsed/Refractory Multiple Myeloma

XPOVIO® is the first XPO1 inhibitor approved in Taiwan for the treatment of adult patients with relapsed/refractory multiple...

February 14, 2025 | News

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

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