BioPharma Drug Approval
TAHO Pharmaceuticals Completes Pivotal Trial for World’s First Anticoagulant Oral Dissolving Film
TAHO Pharmaceuticals is pleased to announce the successful completion of the pivotal trial for TAH3311, the first anticoagulant oral dissolving film (ODF)....
January 22, 2025 | News
Junshi Biosciences Secures Australian Approval for Toripalimab, First Immuno-Oncology Treatment for Nasopharyngeal Carcinoma
Shanghai Junshi Biosciences Co., Ltd , a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercializati...
January 21, 2025 | News
Telix Receives Regulatory Nod for PSMA PET Imaging in Prostate Cancer Across 19 European Nations
Telix Pharmaceuticals Limited announces that it has received a positive decision on the Marketing Authorization Application (MAA) for its prostate ca...
January 20, 2025 | News
Innovent and ASK Pharm Secure NMPA Approval for Limertinib in EGFR T790M-Mutated NSCLC
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality me...
January 20, 2025 | News
Zai Lab’s KarXT NDA Accepted by China’s NMPA for Schizophrenia Treatment
Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the ...
January 20, 2025 | News
AstraZeneca and Daiichi Sankyo’s DATROWAY Secures First US Approval for HR-Positive, HER2-Negative Breast Cancer
First approval in the US for AstraZeneca and Daiichi Sankyo’s DATROWAY based on TROPION-Breast01 results showing 37% reduction in the risk of d...
January 20, 2025 | News
Innovent and ASK Pharm Secure NMPA Approval for Limertinib to Treat EGFR T790M-Mutated NSCLC
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality me...
January 17, 2025 | News
Innovent Biologics Secures Breakthrough Therapy Designation for IBI343 in Advanced Pancreatic Cancer
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality me...
January 16, 2025 | News
ImmunityBio Advances Marketing Authorization Applications for BCG-Unresponsive NMIBC CIS in Europe and the UK
Marketing authorization application for BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in situ (CIS) submitted to Europ...
January 16, 2025 | News
China Approves Sarclisa-Pd for Relapsed Multiple Myeloma, Backed by Pivotal Trial and Real-World Data.
Approval based on positive pivotal ICARIA-MM phase 3 study using the China-based IsaFiRsT real-world study as bridging data, which demonstrated Sarclisa ...
January 13, 2025 | News
SN BioScience Secures FDA IND Clearance for SNB-101 Phase 1b/2 Trial, Targeting Extensive Stage Small Cell Lung Cancer
SN BioScience announced that its lead asset SNB-101 has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administra...
January 13, 2025 | News
MSD’s GARDASIL® Becomes First HPV Vaccine Approved for Males in China
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the National Medical Products Administration (NMPA) of China ...
January 10, 2025 | News
Dizal’s China-Origin Sunvozertinib Secures FDA Priority Review for EGFR Exon20ins NSCLC
If approved, Sunvozertinib as a single oral drug would offer a convenient and safe treatment option with superior efficacy for NSCLC patients with E...
January 08, 2025 | News
Norgine Submits Marketing Authorisation Application to EMA for Eflornithine in High-Risk Neuroblastoma
Norgine announced that it completed its marketing authorisation application filing to European Medicines Agency (EMA) for eflornithine in high-risk ne...
January 07, 2025 | News
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