BioPharma Drug Approval
Singapore Becomes First Southeast Asian Market to Launch BESREMi®️, Setting a New Standard for Rare Disease Care
PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator specializing in haematology and oncology, proudly announces the launch of BES...
September 17, 2024 | News
FDA Approves Eli Lilly's EBGLYSS™ for Moderate-to-Severe Atopic Dermatitis in Patients Aged 12 and Over
Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved EBGLYSS™ (lebrikizumab-lbkz), a targeted IL-13 ...
September 16, 2024 | Analysis
Senhwa Biosciences' Silmitasertib Receives Rare Pediatric Disease Designation from US FDA for Neuroblastoma
Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious d...
September 13, 2024 | News
European Commission Approves BRAFTOVI® + MEKTOVI® Combo for BRAFV600E-Mutated Advanced NSCLC
European approval is based on results from the Phase II PHAROS trial, which showed a meaningful clinical benefit to BRAFV600E mutated advanced ...
September 02, 2024 | News
Zuellig Pharma Secures Exclusive Distribution Agreement with Regeneron to Launch Libtayo® in South Korea and Taiwan
Zuellig Pharma, a leading healthcare solutions company in Asia, has announced an exclusive distribution agreement with Regeneron Ireland DAC, a wholly owne...
August 28, 2024 | News
Telix Pharmaceuticals Submits NDA to FDA for Innovative Brain Cancer Imaging Agent Pixclara®
Telix Pharmaceuticals announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for ...
August 28, 2024 | News
Yipurun's Corina System Receives Approval in China for Treating Moderate-to-Severe Intrauterine Adhesions
Corina Intrauterine Drug-Eluting System ("Corina"), developed by Yipurun (Shanghai) Biotechnology Co., Ltd. ("YPR"), has received approval i...
August 26, 2024 | News
Kelun-Biotech's NDA for Sacituzumab Tirumotecan Accepted by China's NMPA Following Positive Lung Cancer Study Results
New drug application (NDA) for the core product sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) based on the positive results from the pivotal O...
August 21, 2024 | News
AbbVie Secures EU Approval for TEPKINLY® as First Subcutaneous Bispecific Antibody for Relapsed Follicular Lymphoma
AbbVie announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy fo...
August 20, 2024 | News
AbbVie Secures EU Approval for TEPKINLY® as First Subcutaneous Bispecific Antibody for Relapsed Follicular Lymphoma
AbbVie announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy fo...
August 20, 2024 | News
Astellas Pharma Gains NMPA Approval for PADCEV™ in China to Treat Advanced Urothelial Cancer
Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") announced that the Center for Drug Evaluation (CDE) of C...
August 20, 2024 | News
Akeso’s Ivonescimab Granted Priority Review by China's NMPA for First-Line Treatment of PD-L1 Positive NSCLC
Akeso, Inc. announced that the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China (NMPA CDE) ...
August 15, 2024 | News
UAE Approves LEQEMBI® for Early Alzheimer’s Treatment, Marking a Milestone in Regional Healthcare
Eisai Co., Ltd. and Biogen Inc. announced today that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved humanized anti-so...
August 14, 2024 | News
GSK Singapore Secures HSA Approval for Jemperli Combo Therapy in Advanced Endometrial Cancer
GSK Singapore is pleased to announce that the Singapore Health Sciences Authority (HSA) has approved a new indication for Jemperli (dostarlimab). Jemperli ...
August 07, 2024 | News
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