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.

AbbVie Secures Dual FDA Breakthrough Therapy Designations for Temab‑A in Colorectal and Lung Cancers – Next‑Gen c‑Met ADC Advances
Others

AbbVie Secures Dual FDA Breakthrough Therapy Designations for Temab‑A in Colorectal and Lung Cancers – Next‑Gen c‑Met ADC Advances

AbbVie Inc. (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has granted two Breakthrough Therapy Designations (BTDs) for telisotuzumab adizutecan (Temab‑A; ABBV‑400), an investigational next‑generation c‑Met‑directed antibody‑drug…

GeneScience Acquires Global Rights to Megestrol Acetate Oral Suspension from TWi Pharmaceuticals – $100M Deal Transforms Distributor into MAH for Cachexia Therapy

ApicHope's Oral Small‑Molecule GLP‑1R Agonist APH04935 Wins FDA IND Approval – Once‑Daily Pill Targets Obesity in Competitive Weight Loss Market

ApicHope’s Oral Small‑Molecule GLP‑1R Agonist APH04935 Wins FDA IND Approval – Once‑Daily Pill Targets Obesity in Competitive Weight Loss Market

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Johnson & Johnson MedTech's Varipulse Platform Receives FDA Approval for Atrial Fibrillation Treatment
CompanyMedical Device

Johnson & Johnson MedTech’s Varipulse Platform Receives FDA Approval for Atrial Fibrillation Treatment

Bayer AG Receives FDA 510(k) Clearance for MEDRAD Centargo CT Injection System
CompanyMedical Device

Bayer AG Receives FDA 510(k) Clearance for MEDRAD Centargo CT Injection System

Pfizer's Talzenna (talazoparib) Approved by China's NMPA for mCRPC Treatment
CompanyDrug

Pfizer’s Talzenna (talazoparib) Approved by China’s NMPA for mCRPC Treatment

Sanofi's Dupixent Gains EMA Approval for Eosinophilic Esophagitis in Children
CompanyDrug

Sanofi’s Dupixent Gains EMA Approval for Eosinophilic Esophagitis in Children

Amgen’s Tavneos Receives NMPA Approval for ANCA-Associated Vasculitis Treatment in China
CompanyDrug

Amgen’s Tavneos Receives NMPA Approval for ANCA-Associated Vasculitis Treatment in China

Changchun High & New Technology Industries Receives NMPA Approval for Long-Acting Somatropin
CompanyDrug

Changchun High & New Technology Industries Receives NMPA Approval for Long-Acting Somatropin

Huadong Medicine Co., Ltd Receives NMPA Approval for Stelara Biosimilar SaiLeXin
CompanyDrug

Huadong Medicine Co., Ltd Receives NMPA Approval for Stelara Biosimilar SaiLeXin

China Medical System's Opzelura Approved in Hong Kong for Non-segmental Vitiligo Treatment
CompanyDrug

China Medical System’s Opzelura Approved in Hong Kong for Non-segmental Vitiligo Treatment

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