Fineline Cube

Follow:
14446 Articles
CompanyPolicy / Regulatory

China’s CDE Opens Public Comment on “Pioneer Program” for Cell and Gene Therapy Products, Capping Intake at 15 Drugs Per Year

CARsgen 1H 2026: Satricabtagene Autoleucel Wins NMPA Approval as World's First CAR‑T for Solid Tumors; Cash Runway Seen Into 2030
Company

CARsgen 1H 2026: Satricabtagene Autoleucel Wins NMPA Approval as World’s First CAR‑T for Solid Tumors; Cash Runway Seen Into 2030

CompanyDrug

Abbisko Wins NMPA IND Clearance for Pan‑KRAS Inhibitor ABSK211 in Advanced Solid Tumors, Following FDA Green Light

CompanyDeals

VectorBuilder and Lir Therapeutics Forge AI Collaboration to Optimize AAV Capsids for Clinical Translation

Ascentage Pharma 1H 2026: Revenue Jumps 29% to RMB 302 Million as Olverembatinib and Lisaftoclax Power Commercial Growth
Company

Ascentage Pharma 1H 2026: Revenue Jumps 29% to RMB 302 Million as Olverembatinib and Lisaftoclax Power Commercial Growth

Jiangsu Hengrui 1H 2026: Innovative Drug Sales Jump 16.4% to RMB 8.8 Billion, Offset Generic Drag as R&D Spending Climbs 19%
Company

Jiangsu Hengrui 1H 2026: Innovative Drug Sales Jump 16.4% to RMB 8.8 Billion, Offset Generic Drag as R&D Spending Climbs 19%

CompanyDeals

LEO Pharma to Acquire Global Rights to Dersimelagon From Tanabe – Late‑Stage Oral Therapy for Rare Protoporphyrias Nears FDA Decision

CompanyDrug

Haisco Pharmaceutical Wins NMPA Clinical Approval for Nav1.8 Inhibitor HSK51155 – Pain Drug Licensed to AbbVie in USD 700 Million Deal Advances in China

CompanyDrug

Lepu Medical’s siRNA Drug MWN117 Wins NMPA Clinical Trial Approval for Overweight and Obesity – INHBE‑Targeting Therapy Shows Synergy Potential with GLP‑1 Agonists

Policy / Regulatory

FDA Issues Discussion Paper on GenAI‑Enabled Medical Devices – Seeks Feedback on Risk Framework, Premarket Evaluation and Postmarket Monitoring by October 19

CompanyMedical Device

Johnson & Johnson Wins U.S. 510(k) Clearance for MONARCH QUEST 3 Software Update – Advancing Robotic Bronchoscopy Navigation and Targeting

Trump Picks White House Policy Advisor Heidi Overton to Lead FDA – Replacing Acting Commissioner Kyle Diamantas After Makary's Resignation
Policy / Regulatory

Trump Picks White House Policy Advisor Heidi Overton to Lead FDA – Replacing Acting Commissioner Kyle Diamantas After Makary’s Resignation