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BioPharma Drug Approval

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

EU Commission Approves Pfizer's ABRYSVO™ for Infant and Elderly RSV Protection

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for ABRYSVO™, the company’s bival...

August 25, 2023 | News

Akeso's Ebdarokimab NDA Accepted by China NMPA for Psoriasis

Ebdarokimab is Akeso's 6th self-developed innovative drug that has been successfully approved for marketing/NDA submitted, the first patented domestic inno...

August 25, 2023 | News

CanariaBio's MAb-AR20.5 for Pancreatic Cancer Granted FDA Orphan Drug Designation

CanariaBio Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative immunotherapies for cancer, anno...

August 22, 2023 | News

Everest Medicines' Partner Calliditas Therapeutics Gets FDA Priority Review for Nefecon® in IgA Nephropathy

"We congratulate our partner Calliditas for being granted priority review by the FDA for full approval and taking a step closer to offering this first-in-d...

August 22, 2023 | Regulatory

Innovent's SINTBILO® Receives NMPA Approval for Treating Hypercholesterolemia

The prevalence of cardiovascular diseases is continuously increasing in China, among which atherosclerotic cardiovascular disease (ASCVD) is the leadi...

August 17, 2023 | News

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