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.

FDA Approves Priovant's LISRAYA (Brepocitinib) for Adult Dermatomyositis – First Oral Targeted JAK1/TYK2 Therapy in the Indication
CompanyDrug

FDA Approves Priovant’s LISRAYA (Brepocitinib) for Adult Dermatomyositis – First Oral Targeted JAK1/TYK2 Therapy in the Indication

The U.S. Food and Drug Administration (FDA) has approved LISRAYA (brepocitinib) 30 mg tablets, developed by Priovant Therapeutics (a Roivant Sciences / Pfizer venture), for the treatment of adult dermatomyositis…

AnnJi Advances AJ201 into Pivotal Phase 3 ROMA‑KD Trial – The Only Investigational Therapy for SBMA in Late‑Stage Development Worldwide

AnnJi Advances AJ201 into Pivotal Phase 3 ROMA‑KD Trial – The Only Investigational Therapy for SBMA in Late‑Stage Development Worldwide

Asymchem's Tianjin Macromolecule Site Passes First FDA Pre‑Approval Inspection – EIR Issued for Commercial API Facility

Asymchem’s Tianjin Macromolecule Site Passes First FDA Pre‑Approval Inspection – EIR Issued for Commercial API Facility

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Novo Nordisk Secures FDA Approval for Rybelsus to Reduce Cardiovascular Risk in Type 2 Diabetes
CompanyDrug

Novo Nordisk Secures FDA Approval for Rybelsus to Reduce Cardiovascular Risk in Type 2 Diabetes

Kelun-Biotech's Trastuzumab Botidotin Approved by NMPA for HER2-Positive Breast Cancer
CompanyDrug

Kelun-Biotech’s Trastuzumab Botidotin Approved by NMPA for HER2-Positive Breast Cancer

Huadong Medicine Secures NMPA Approval for Relmapirazin Injection, Complementing MediBeacon TGFR Device
CompanyDrug

Huadong Medicine Secures NMPA Approval for Relmapirazin Injection, Complementing MediBeacon TGFR Device

Sinclair’s MaiLi Precise Receives NMPA Acceptance Notice for Class III Device
CompanyMedical Device

Sinclair’s MaiLi Precise Receives NMPA Acceptance Notice for Class III Device

UCB Biosciences Receives NMPA Marketing Authorization for Zilucoplan (Zilbrysq) in Adult Generalized Myasthenia Gravis
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UCB Biosciences Receives NMPA Marketing Authorization for Zilucoplan (Zilbrysq) in Adult Generalized Myasthenia Gravis

GSK Receives China NMPA Approval for Shingrix in Immunocompromised Adults
CompanyDrug

GSK Receives China NMPA Approval for Shingrix in Immunocompromised Adults

Arcutis Biotherapeutics Receives FDA Approval for ZORYVE (Roflumilast) Cream in Children 2‑5 Years with Atopic Dermatitis
CompanyDrug

Arcutis Biotherapeutics Receives FDA Approval for ZORYVE (Roflumilast) Cream in Children 2‑5 Years with Atopic Dermatitis

Amoytop Biotech Secures NMPA Approval for Pegbinterferon Combination Therapy in Chronic Hepatitis B
CompanyDrug

Amoytop Biotech Secures NMPA Approval for Pegbinterferon Combination Therapy in Chronic Hepatitis B

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