Fineline Cube

Follow:
14409 Articles
Henlius’ POHERDY (HLX11) Receives Full FDA Approval for All Pertuzumab Indications
CompanyDrug

Henlius’ POHERDY (HLX11) Receives Full FDA Approval for All Pertuzumab Indications

Hangzhou Bio‑Sincerity Pharma‑Tech Secures NMPA Approval for BIOS2242 Oral Solution in Acute Ischemic Stroke
CompanyDrug

Hangzhou Bio‑Sincerity Pharma‑Tech Secures NMPA Approval for BIOS2242 Oral Solution in Acute Ischemic Stroke

NMPA Launches Pilot Program to Cut Review Time for Overseas‑Manufactured Drug Supplementary Applications
Others

NMPA Launches Pilot Program to Cut Review Time for Overseas‑Manufactured Drug Supplementary Applications

FDA Issues Boxed Warning on Elevidys (delandistrogene moxeparvovec‑rokl) – Use Limited to Ambulatory DMD Patients Aged 4+
Policy / Regulatory

FDA Issues Boxed Warning on Elevidys (delandistrogene moxeparvovec‑rokl) – Use Limited to Ambulatory DMD Patients Aged 4+

Zelgen Biopharma’s ZG006 (Alveltamig) Receives FDA Orphan‑Drug Designation for Neuroendocrine Carcinomas
CompanyDrug

Zelgen Biopharma’s ZG006 (Alveltamig) Receives FDA Orphan‑Drug Designation for Neuroendocrine Carcinomas

WestVac BioPharma & West China Hospital Secure NMPA Clearance for China’s First Acne Therapeutic Vaccine
CompanyDrug

WestVac BioPharma & West China Hospital Secure NMPA Clearance for China’s First Acne Therapeutic Vaccine

BrightGene Boosts Stake in Geek Gene to 12.8% with RMB 50 M Injection – Expanding Cell‑Therapy Portfolio
CompanyDeals

BrightGene Boosts Stake in Geek Gene to 12.8% with RMB 50 M Injection – Expanding Cell‑Therapy Portfolio

Changchun GeneScience Secures NMPA Approval for GS3‑007a Dry Suspension & Green‑lights GenSci140 ADC Trials
CompanyDrug

Changchun GeneScience Secures NMPA Approval for GS3‑007a Dry Suspension & Green‑lights GenSci140 ADC Trials

BrightGene Secures NMPA Nod for BGM1812 Obesity Trial, FDA Grants Trial Clearance
CompanyDrug

BrightGene Secures NMPA Nod for BGM1812 Obesity Trial, FDA Grants Trial Clearance

Changchun GeneScience Secures FDA Approval for GenSci143 – Bispecific ADC Targeting B7‑H3 & PSMA in Advanced Solid Tumors
CompanyDrug

Changchun GeneScience Secures FDA Approval for GenSci143 – Bispecific ADC Targeting B7‑H3 & PSMA in Advanced Solid Tumors

Qyuns Therapeutics Receives NMPA Trial Approvals for QX027N – Long‑Acting Bispecific Antibody Targeting Asthma and Atopic Dermatitis
CompanyDrug

Qyuns Therapeutics Receives NMPA Trial Approvals for QX027N – Long‑Acting Bispecific Antibody Targeting Asthma and Atopic Dermatitis

Suzhou Zelgen Secures NMPA Trial Approval for ZG006 (Alveltamig) – First‑In‑Class Trispecific Antibody for Advanced Neuroendocrine Carcinoma
CompanyDrug

Suzhou Zelgen Secures NMPA Trial Approval for ZG006 (Alveltamig) – First‑In‑Class Trispecific Antibody for Advanced Neuroendocrine Carcinoma