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BioPharma Drug Approval

FDA Grants Orphan Drug Status to GC Biopharma's Thrombocytopenic Purpura Drug in South Korea

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

FDA Clears Transcenta for Global Phase III Trial of Osemitamab in Gastric Cancer

Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, resear...

October 04, 2023 | News

Hong Kong's Akeso Receives FDA IND Clearance for AK117 in MDS Combo with Azacitidine

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

Everest Medicines Gets Taiwan Approval for XERAVA® in Treating Intra-Abdominal Infections

"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

Chinese Patent Granted for CytoMed Therapeutics' Licensed iPSC-Based Technology

"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

MicuRx Receives FDA QIDP and Fast Track Designation for Contezolid & Acefosamil

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

Golidocitinib Granted Priority Review by China NMPA for the Treatment of r/r PTCL

"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/ADEL Receives FDA Clearance for Alzheimer's Treatment IND Application (ADEL-Y01)

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

BioRay's Zuberitamab (Anruixi®) First Domestic Anti-CD20 Antibody Approved in China

In preclinical studies, Anruixi® showed stronger antibody-dependent cell-mediated cytotoxicity (ADCC), a larger volume of distribution at steady state,...

September 14, 2023 | News

Exelixis and Insilico Medicine Ink Global License Deal for ISM3091, a Leading USP1 Inhibitor

— ISM3091 is a highly selective, orally bioavailable small molecule inhibitor of USP1 identified through Insilico Medicine's artificial int...

September 14, 2023 | News

Singapore's Biosyngen Gets FDA Nod for BRL03 Trials in Advanced Solid Tumors

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

Gloria Biosciences' Zimberelimab Approved in China for Recurrent Cervical Cancer

Guangzhou Gloria Biosciences ("GloriaBio"), a commercial stage biopharmaceutical company focusing on the discovery, development and commercialization of bi...

September 07, 2023 | News

Menarini's ELZONRIS® (Tagraxofusp) Receives Orphan Drug Designation for BPDCN by Japanese Ministry of Health

The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-own...

August 31, 2023 | Regulatory

HUTCHMED Receives Breakthrough Therapy Designation in China for Savolitinib for Gastric Cancer

The study of savolitinib is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and tolerability of savoli...

August 29, 2023 | News

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