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BioPharma Drug Approval

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

Astellas Pharma Announces NMPA Approval of Zolbetuximab in China for Advanced Gastric and GEJ Cancer

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the National Medical Products Administration (N...

January 06, 2025 | News

Everest Medicines Announces NEFECON® NRDL Implementation in China to Expand Access for IgAN Patients

Everest Medicines (HKEX 1952.HK, 'Everest', or the 'Company'), a biopharmaceutical company focused on the discovery, clinical development, manufacturing an...

January 06, 2025 | News

Japan Approves TEPOXX as First Antiviral Treatment for Orthopoxviruses, Including Smallpox, Mpox, and Cowpox

Regulatory decision marks first approval in Japan of an antiviral for the treatment of orthopoxviruses including smallpox, mpox and cowpox Japan Bi...

January 03, 2025 | News

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