BioPharma Drug Approval
Hong Kong Approves Eli Lilly’s Mounjaro® as First Dual-Receptor Agonist for Obesity and Type 2 Diabetes
Adults taking Mounjaro in a clinical trial lost on average 48 lb. at the highest dose1,2 Mounjaro delivered superior A1C reductions versus all comparato...
October 28, 2024 | News
MicuRx Achieves Milestone with Successful Phase I Trial of Novel Antibacterial MRX-5 in Australia
Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH) announced the successful completion of Phase I clinical trial of MRX-5 in Australi...
October 28, 2024 | News
Everest Medicines’ VELSIPITY® Approved for Ulcerative Colitis in Greater Bay Area Hospitals under "Hong Kong and Macau Medicine Connect" Policy
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing an...
October 25, 2024 | News
EpiVax and CUBRC Secure $2M FDA Contract to Develop T Cell Assay Standards for Generic Drug Immunogenicity
EpiVax, Inc. ("EpiVax") and CUBRC, Inc. ("CUBRC") announce that they have been awarded a two-year, $2 million contract (#75F40124C00094) from the...
October 25, 2024 | News
Australia's Telix Pharmaceuticals Secures FDA Priority Review for Pixclara® (TLX101-CDx) Glioma Imaging Agent
Telix Pharmaceuticals announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ...
October 24, 2024 | News
SK bioscience Gains Approval for SKYCellflu in Indonesia, Expanding Global Reach for Cell-Cultured Influenza Vaccines
This approval paves the way for exports to the world's fourth most populous country. SK bioscience aims to continue to grow as a global vaccine brand be...
October 23, 2024 | News
South Korea Approves XPOVIO® for Third Indication in Multiple Myeloma Treatment
This approval for XPOVIO® for the treatment of patients with multiple myeloma (MM) marks the third approved indication of the drug in South...
October 21, 2024 | News
Everest Medicines Gains TFDA Approval for NEFECON® to Treat IgA Nephropathy in Taiwan
Everest Medicines , a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeut...
October 21, 2024 | News
Eisai and Biogen to Seek Reconsideration After TGA Declines Initial Approval of Lecanemab for Early Alzheimer’s Treatment in Australia
Eisai Co., Ltd. and Biogen Inc. announced that the Therapeutic Goods Administration (TGA) of Australia issued a public statement about the initial de...
October 18, 2024 | News
CSL Vifor and Travere Therapeutics Secure Swissmedic Approval for FILSPARI in Treatment of IgA Nephropathy
CSL Vifor and Travere Therapeutics, announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults w...
October 18, 2024 | News
Antengene’s XPOVIO® Gains Third Approval in South Korea for Multiple Myeloma Treatment
This approval for XPOVIO® for the treatment of patients with multiple myeloma (MM) marks the third approved indication of the drug in South...
October 18, 2024 | News
Dizal Receives Fourth Breakthrough Therapy Designation for Sunvozertinib in EGFR Exon20ins NSCLC
Fourth Breakthrough Therapy Designation for sunvozertinib in NSCLC with EGFR exon20ins Dizal (SSE:688192), a biopharmaceutical company committed to d...
October 14, 2024 | News
Genentech's Itovebi™ Wins FDA Approval for HR-Positive Breast Cancer, Doubling Progression-Free Survival in PIK3CA-Mutated Cases
– Approval is based on Phase III INAVO120 results, showing the ItovebiTM (inavolisib)-based regimen more than doubled progression-free sur...
October 11, 2024 | News
Telix Pharmaceuticals Secures TGA Approval for Illuccix® to Select Patients for PSMA-Targeted Radionuclide Therapy
Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Australian Therapeutic Goods Administration (TGA) has approved the us...
October 08, 2024 | News
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