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.

Dezhan Healthcare Subsidiary Secures FDA IND Clearance for WYY026B Injection in Acute Ischemic Stroke – First‑in‑Class Neuroprotective Agent Advances to U.S. Clinical Trials
CompanyDrug

Dezhan Healthcare Subsidiary Secures FDA IND Clearance for WYY026B Injection in Acute Ischemic Stroke – First‑in‑Class Neuroprotective Agent Advances to U.S. Clinical Trials

Dezhan Healthcare Co., Ltd. (SHE: 000813) announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for WYY026B Injection, a Category 1 chemical…

Sunshine Lake Pharma Wins NMPA Approval for Dual Insulin Analogue Injection – Fixed‑Ratio Degludec/Aspart Targets Fasting and Postprandial Glucose in One Formulation

Sunshine Lake Pharma Wins NMPA Approval for Dual Insulin Analogue Injection – Fixed‑Ratio Degludec/Aspart Targets Fasting and Postprandial Glucose in One Formulation

Hengrui Pharma's Fluzoparib Enters EMA Review for Prostate Cancer – First China‑Developed PARP Inhibitor Targets European mCRPC Market

Hengrui Pharma’s Fluzoparib Enters EMA Review for Prostate Cancer – First China‑Developed PARP Inhibitor Targets European mCRPC Market

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Acotec Secures NMPA Approval for Acotrace Disposable Catheter Sheath
CompanyMedical Device

Acotec Secures NMPA Approval for Acotrace Disposable Catheter Sheath

Novartis Secures FDA Accelerated Approval for Scemblix in Newly Diagnosed CML Patients
CompanyDrug

Novartis Secures FDA Accelerated Approval for Scemblix in Newly Diagnosed CML Patients

Xi'an Xintong Pharma's Pradefavir Wins NMPA Nod for Chronic Hepatitis B Treatment
CompanyDrug

Xi’an Xintong Pharma’s Pradefavir Wins NMPA Nod for Chronic Hepatitis B Treatment

Eli Lilly's Mounjaro Approved in Hong Kong for Obesity and Type 2 Diabetes Treatment
CompanyDrug

Eli Lilly’s Mounjaro Approved in Hong Kong for Obesity and Type 2 Diabetes Treatment

Merck's Keytruda Gains Two Additional EU Indications for Gynecologic Cancer Treatment
CompanyDrug

Merck’s Keytruda Gains Two Additional EU Indications for Gynecologic Cancer Treatment

AstraZeneca's Fasenra Approved by EU for Eosinophilic Granulomatosis Treatment
CompanyDrug

AstraZeneca’s Fasenra Approved by EU for Eosinophilic Granulomatosis Treatment

AstraZeneca's Zoladex Receives NMPA Approval for Higher Dosage Form in Breast Cancer Treatment
CompanyDrug

AstraZeneca’s Zoladex Receives NMPA Approval for Higher Dosage Form in Breast Cancer Treatment

Wantai Biological's P85 Ab Detection Kit Receives NMPA Approval for Nasopharyngeal Carcinoma Screening
CompanyMedical Device

Wantai Biological’s P85 Ab Detection Kit Receives NMPA Approval for Nasopharyngeal Carcinoma Screening

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