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Aficamten Wins China Approval as HCM Drug in Global First for Sanofi
CompanyDrug

Aficamten Wins China Approval as HCM Drug in Global First for Sanofi

Haisco Wins NMPA Clinical Approval for Four Category 1 Drugs, Advancing Pipeline
CompanyDrug

Haisco Wins NMPA Clinical Approval for Four Category 1 Drugs, Advancing Pipeline

Orelabrutinib First BTK Inhibitor to Hit Phase 3 in Lupus as InnoCare NMPA Filing Cleared
CompanyDrug

Orelabrutinib First BTK Inhibitor to Hit Phase 3 in Lupus as InnoCare NMPA Filing Cleared

Saizeng Medical Licenses TSHR Antibody to Yarrow for $1.4B in Graves' Disease Deal
CompanyDeals

Saizeng Medical Licenses TSHR Antibody to Yarrow for $1.4B in Graves’ Disease Deal

Zhicheng's TAVR Robotic System Enters NMPA Innovation Pathway
CompanyMedical Device

Zhicheng’s TAVR Robotic System Enters NMPA Innovation Pathway

ENHERTU Wins FDA Approval as First-Line HER2 Breast Cancer Therapy
CompanyDrug

ENHERTU Wins FDA Approval as First-Line HER2 Breast Cancer Therapy

FDA Removes Key RWE Limitation, Allowing Drug and Device Submissions Without Individual Patient Data
Policy / Regulatory

FDA Removes Key RWE Limitation, Allowing Drug and Device Submissions Without Individual Patient Data

Sanofi’s Tolebrutinib Fails Phase 3 PPMS Endpoint, Halting Registration Plans
CompanyDrug

Sanofi’s Tolebrutinib Fails Phase 3 PPMS Endpoint, Halting Registration Plans

Konruns Doses First Patient in Phase 2 Esophageal Cancer Trial for KC1036
CompanyDrug

Konruns Doses First Patient in Phase 2 Esophageal Cancer Trial for KC1036

Johnson & Johnson's TECVAYLI Gets FDA Priority Review for Myeloma Combo
CompanyDrug

Johnson & Johnson’s TECVAYLI Gets FDA Priority Review for Myeloma Combo

uBriGene Partners with Circurna on circRNA Manufacturing for Global Trials
CompanyDeals

uBriGene Partners with Circurna on circRNA Manufacturing for Global Trials

Dren Bio, Sanofi Forge $1.8B B‑Cell Therapy Deal with US Co‑Promote Option
CompanyDeals

Dren Bio, Sanofi Forge $1.8B B‑Cell Therapy Deal with US Co‑Promote Option