BioPharma Drug Approval
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
FDA Grants Rare Pediatric Disease Designation to META Pharmaceuticals' Investigational Drug META-001-PH
META Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to its investiga...
August 06, 2024 | News
Pierre Fabre Laboratories Receives Positive CHMP Opinion for BRAFTOVI® + MEKTOVI® in Advanced NSCLC Treatment
Pierre Fabre Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval ...
July 29, 2024 | News
Sugemalimab Becomes First Anti-PD-L1 mAb Approved in Europe for First-Line Treatment of NSCLC
Sugemalimab becomes the world's first anti-PD-L1 monoclonal antibody (mAb) approved in Europe for first-line treatment of both squamous and non...
July 29, 2024 | News
IASO Biotechnology's IND Application for IASO-782 Injection Approved by NMPA for Systemic Lupus Erythematosus Treatment
IASO Biotechnology ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therap...
July 26, 2024 | News
FDA Accepts Telix's NDA for TLX007-CDx, Expanding PSMA-PET Imaging Access
Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announces that the United States (U.S.) Food and Drug Administration (FDA) has...
July 24, 2024 | News
Everest Medicines' NEFECON® sNDA Accepted by China’s NMPA, Paving the Way for First Full Approval of IgA Nephropathy Treatment
Everest Medicines, a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeuti...
July 18, 2024 | News
Biosyngen's Groundbreaking CAR-T Therapy BRG01 Approved for Phase II Clinical Trial in China
Biosyngen, a leading biotechnology company focused on the development of innovative cell therapies, recently announced that the Center for Drug Evaluation ...
July 17, 2024 | News
Mabwell's Novel Nectin-4 ADC Approved for Phase II Clinical Trial in Treating Triple-Negative Breast Cancer
Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821)...
July 16, 2024 | News
ADM Korea to Submit IND for Niclosamide-Based Combination Therapy for Prostate Cancer
IND for clinical study for combination therapy with hormone therapy in prostate cancer patients to be submitted in August, 2024. Niclosamide-based metab...
July 12, 2024 | News
Eisai and Biogen Announce Approval of LEQEMBI® (Lecanemab) for Alzheimer’s Disease Treatment in Hong Kong
LEQEMBI is now available for patients with mild cognitive impairment (MCI) or mild dementia, collectively referred to as early AD, the population in which ...
July 11, 2024 | News
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