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BioPharma Drug Approval

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

Kelun-Biotech's NDA for Sacituzumab Tirumotecan Accepted by China's NMPA Following Positive Lung Cancer Study Results

New drug application (NDA) for the core product sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) based on the positive results from the pivotal O...

August 21, 2024 | News

AbbVie Secures EU Approval for TEPKINLY® as First Subcutaneous Bispecific Antibody for Relapsed Follicular Lymphoma

AbbVie announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy fo...

August 20, 2024 | News

AbbVie Secures EU Approval for TEPKINLY® as First Subcutaneous Bispecific Antibody for Relapsed Follicular Lymphoma

AbbVie announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy fo...

August 20, 2024 | News

Astellas Pharma Gains NMPA Approval for PADCEV™ in China to Treat Advanced Urothelial Cancer

Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") announced that the Center for Drug Evaluation (CDE) of C...

August 20, 2024 | News

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