Product approvals

Explore the landscape of product approvals in China’s pharmaceutical industry. Fineline Info & Tech delivers reliable data and insights on product approvals to help you navigate complexities with precision and clarity. Stay informed and enhance your decision-making at flcube.com.

Shanghai Ark Biopharmaceutical's AK0406 Receives FDA IND Clearance for Phase 2 Trial – Long‑Acting Antiviral‑Fc Conjugate Advances Toward Influenza Prevention
CompanyDrug

Shanghai Ark Biopharmaceutical’s AK0406 Receives FDA IND Clearance for Phase 2 Trial – Long‑Acting Antiviral‑Fc Conjugate Advances Toward Influenza Prevention

Shanghai Ark Biopharmaceutical Co., Ltd. (Ark Biosciences) announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AK0406, a long‑acting antiviral drug‑Fc…

T-MAXIMUM's MT027 Wins FDA Clearance for Phase 2 Study – Non‑Viral Allogeneic B7‑H3 CAR‑T Targets Advanced Solid Tumor Brain Metastases

T-MAXIMUM’s MT027 Wins FDA Clearance for Phase 2 Study – Non‑Viral Allogeneic B7‑H3 CAR‑T Targets Advanced Solid Tumor Brain Metastases

Five Innovative Therapies Enter the Rare Disease R&D Pilot Initiative – Spanning Blau Syndrome, Angelman Syndrome, ALS and Charcot‑Marie‑Tooth Disease

Five Innovative Therapies Enter the Rare Disease R&D Pilot Initiative – Spanning Blau Syndrome, Angelman Syndrome, ALS and Charcot‑Marie‑Tooth Disease

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CompanyDrug

Merck’s Lagevrio Receives Emergency Conditional Approval from China’s NMPA

CompanyDrug

AstraZeneca’s Nexium Approved by NMPA for Adolescent GERD Treatment

CompanyDeals

Guangzhou Mygene Raises ‘Hundreds of Millions’ in Series C Financing Led by Efund Capital

CompanyDrug

InnoCare Pharma Receives Hong Kong Approval for Tafasitamab in DLBCL

CompanyDrug

Junshi Biosciences’ PD-1 Inhibitor Tuoyi Faces FDA Review Delay

CompanyDrug

Hengrui Pharmaceuticals Receives New Approval for Remimazolam Tosylate

CompanyMedical Device

Hangzhou Biotest Receives FDA EUA for COVID-19 Antigen Self-Testing Reagent

CompanyDrug

Shyndec’s Generic Cytosar-U Gains Marketing Approval in China

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