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BioPharma Drug Approval

Ascentage Pharma’s APG-2449 Tyrosine Kinase Inhibitor Cleared for Two Registrational Phase III Studies in NSCLC Patients

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet med...

October 08, 2024 | News

Akeso's Cadonilimab Gains Approval for First-Line Treatment of Advanced Gastric Cancer in China

Akeso (9926. HK) announced that its internally developed PD-1/CTLA-4 bispecific antibody, cadonilimab, has received approval from the National Medical Prod...

October 01, 2024 | News

BioCity Biopharma's SC0062 Receives Breakthrough Therapy Designation from NMPA for Treatment of IgA Nephropathy

BioCity Biopharma (BioCity) announced its endothelin receptor type A (ETA) selective antagonist SC0062 has been granted the Breakthrough Therapy Desig...

September 27, 2024 | News

Innovent Biologics' New Drug Application for Picankibart Accepted by China's NMPA for Treatment of Moderate to Severe Plaque Psoriasis

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality me...

September 27, 2024 | News

Nuance Pharma Expands Bentrio® Nasal Spray Launch in Asia, Files for Mainland China Approval

Nuance Pharma successfully launched Bentrio® nasal spray for protection against airborne particles in Hong Kong and filed request for ...

September 24, 2024 | News

Antengene Secures Thailand FDA Approval for XPOVIO®: The First and Only XPO1 Inhibitor in the Market

XPOVIO® is the first and only approved XPO1 inhibitor in Thailand. XPOVIO® has been approved for multiple indicatio...

September 24, 2024 | News

CD Biopharma Receives FDA Clearance for IND Application of CD-001, Paving the Way for Phase I Clinical Trial

CD (Suzhou) Biopharma has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application...

September 23, 2024 | News

Singapore Becomes First Southeast Asian Market to Launch BESREMi®️, Setting a New Standard for Rare Disease Care

PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator specializing in haematology and oncology, proudly announces the launch of BES...

September 17, 2024 | News

FDA Approves Eli Lilly's EBGLYSS™ for Moderate-to-Severe Atopic Dermatitis in Patients Aged 12 and Over

Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved EBGLYSS™ (lebrikizumab-lbkz), a targeted IL-13 ...

September 16, 2024 | Analysis

Senhwa Biosciences' Silmitasertib Receives Rare Pediatric Disease Designation from US FDA for Neuroblastoma

Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious d...

September 13, 2024 | News

European Commission Approves BRAFTOVI® + MEKTOVI® Combo for BRAFV600E-Mutated Advanced NSCLC

European approval is based on results from the Phase II PHAROS trial, which showed a meaningful clinical benefit to BRAFV600E mutated advanced ...

September 02, 2024 | News

Zuellig Pharma Secures Exclusive Distribution Agreement with Regeneron to Launch Libtayo® in South Korea and Taiwan

Zuellig Pharma, a leading healthcare solutions company in Asia, has announced an exclusive distribution agreement with Regeneron Ireland DAC, a wholly owne...

August 28, 2024 | News

Telix Pharmaceuticals Submits NDA to FDA for Innovative Brain Cancer Imaging Agent Pixclara®

Telix Pharmaceuticals announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for ...

August 28, 2024 | News

Yipurun's Corina System Receives Approval in China for Treating Moderate-to-Severe Intrauterine Adhesions

Corina Intrauterine Drug-Eluting System ("Corina"), developed by Yipurun (Shanghai) Biotechnology Co., Ltd. ("YPR"), has received approval i...

August 26, 2024 | News

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