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Drug Approval

Chipscreen Biosciences Secures NMPA Approval for Phase III Trial of Chiauranib in ES-SCLC Treatment

Shenzhen Chipscreen Biosciences Co., Ltd. (hereinafter referred to as "Chipscreen Biosciences") and its wholly-owned subsidiary Chengdu Chipscreen Ph...

November 04, 2024 | News

Taiwan’s CStone Secures UK Approval for Sugemalimab as First-Line Treatment for Metastatic NSCLC

This approval marks the second international marketing authorization for sugemalimab outside of China, following its recent approval by the Eur...

November 01, 2024 | News

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