BioPharma Drug Approval
CANbridge Pharmaceuticals Inc. (1228.HK), a global biopharmaceutical company, with a foundation in China, committed to the research, development ...
October 09, 2023 | News
When designated as an orphan drug, there are incentives such as tax credits for clinical development costs and exemptions from PDUFA user fees Initial Pedi...
October 06, 2023 | News
Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, resear...
October 04, 2023 | News
The upcoming study, known as a randomized, double-blind, global multi-center Phase II study, is set to be conducted in the United States. Based on th...
September 29, 2023 | News
"The NDA approval of XERAVA® in Taiwan marks an important step towards bringing this novel, critical therapy for complicated intra-abdominal ...
September 28, 2023 | News
"We're thrilled to strengthen our existing suite of patents," said Peter Choo, Chairman of CytoMed. "Now this novel iPSC-based technology has been gra...
September 26, 2023 | News
The QIDP and Fast Track designations were created as part of the Food and Drug Administration Safety and Innovation Act, FDASIA (June 2012), Titl...
September 25, 2023 | News
"Patients with relapsed or refractory PTCL worldwide face limited treatment options and a poor prognosis. We are pleased with the CDE's decision to grant p...
September 22, 2023 | News
Oscotec and ADEL are jointly developing a novel disease-modifying immunotherapy agent (ADEL-Y01) targeting tau protein accumulation in the AD brain. ADEL-Y...
September 15, 2023 | News
In preclinical studies, Anruixi® showed stronger antibody-dependent cell-mediated cytotoxicity (ADCC), a larger volume of distribution at steady state,...
September 14, 2023 | News
— ISM3091 is a highly selective, orally bioavailable small molecule inhibitor of USP1 identified through Insilico Medicine's artificial int...
September 14, 2023 | News
Notably, BRL03 is also the first TCR-T product developed by Biosyngen to enter clinical trials. This significant achievement is attributed to the...
September 12, 2023 | News
Guangzhou Gloria Biosciences ("GloriaBio"), a commercial stage biopharmaceutical company focusing on the discovery, development and commercialization of bi...
September 07, 2023 | News
The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-own...
August 31, 2023 | Regulatory
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