Drug Approval
Kexing Biopharm’s GB18 Receives IND Approval in China and U.S. for Cancer Cachexia Treatment
Kexing Biopharm (688136.SH) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) applica...
May 30, 2025 | News
Adalvo Inks Licensing Deal with Formosa Pharmaceuticals for Novel Ophthalmic Steroid in Europe and Brazil
Adalvo announces the signing of an exclusive licensing agreement with Formosa Pharmaceuticals for the commercialisation of Clobetasol propio...
May 29, 2025 | News
Eisai’s DAYVIGO® Approved in China to Treat Insomnia, Targeting Over 170 Million Adults
Eisai Co., Ltd. announced that the in-house-discovered and developed orexin receptor antagonist DAYVIGO® (generic name: lemborexant) has been app...
May 29, 2025 | News
RemeGen’s Telitacicept Approved in China as First Dual-Target Biologic for Generalized Myasthenia Gravis
RemeGen Co., Ltd.(688331.SH / 09995.HK) announced that Telitacicept has officially been approved for marketing in China by the National Medical Produc...
May 28, 2025 | News
AnnJi Reports Promising Phase 1/2a Results for AJ201 in Rare Neuromuscular Disease SBMA
AnnJi Pharmaceutical Co., Ltd., a clinical-stage Taiwanese biotechnology company focused on addressing unmet medical needs in dermatology, neurology, and r...
May 22, 2025 | News
Kelun-Biotech's Fourth Indication for ADC sac-TMT Accepted for Priority Review in China
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that a new indication application (the "Application") for the Company's trophob...
May 22, 2025 | News
Singapore Approves Dupixent as First Biologic Treatment for Uncontrolled COPD with Raised Eosinophils
The Health Sciences Authority (HSA) has approved Dupixent (dupilumab) for adults as an add-on maintenance treatment for uncontrolled chronic obstru...
May 14, 2025 | News
BioDlink Supports Junshi Biosciences in Achieving IND Approval for JS212, Its First Bispecific ADC
BioDlink congratulates Junshi Biosciences on receiving IND approval from China's NMPA for JS212, the company...
May 09, 2025 | News
China Grants Full Approval to Everest Medicines’ NEFECON® as First and Only Etiological Treatment for IgA Nephropathy
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, a...
May 07, 2025 | Regulatory
IGI’s Trispecific Antibody ISB 2001 Receives FDA Fast Track Designation for Relapsed Multiple Myeloma
IGI, a global, fully integrated, clinical-stage biotechnology company focused on multi-species™ oncology product development, announced that th...
May 06, 2025 | News
Fangzhou Launches Otsuka’s Iclusig® Online for Leukemia Care in China
Fangzhou Inc. , a leader in Internet healthcare solutions, announced the availability of Otsuka Pharmaceutical's third-generation tyrosine kinase inhi...
May 06, 2025 | News
InnoCare’s Zurletrectinib Granted Priority Review in China for NTRK Fusion-Positive Solid Tumors
InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced that its new genera...
May 05, 2025 | News
S&E bio Receives MFDS Approval for Korea’s First Clinical Trial of Exosome-Based Stroke Therapy
S&E bio Co., Ltd., a biotechnology company specializing in exosomal microRNA-based therapies, has received approval from Korea's Ministry of Food...
May 01, 2025 | News
Everest Medicines Secures Hong Kong Approval for VELSIPITY® in Ulcerative Colitis
Everest Medicines , a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeu...
April 30, 2025 | News
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