# FDA
Latest news and articles about FDA
Total: 5 articles found
From Shijiazhuang to the States: CSPC Pharma’s Global Ambitions Get FDA Boost
Chinese pharmaceutical giant CSPC has received US FDA approval to begin clinical trials for its long-acting octreotide injection, a treatment for acromegaly and neuroendocrine tumors. This move highlights the industry's shift toward high-barrier formulations as Chinese firms seek to escape domestic price pressures by expanding into the US market.
From Outsourcing to Outpacing: China’s Biotech Leap Triggers Alarm in Washington
Pfizer’s multi-billion dollar partnership with Innovent Biologics underscores China’s rapid ascent from a pharmaceutical follower to a global innovation hub. As Chinese firms begin to outperform Western incumbents in clinical trials and regulatory speed, Washington is increasingly viewing the biotech sector through a lens of national security and competition.
Neural Rewiring: Shanghai Biotech Secures Global First with Dual US-China Approval for Epilepsy Cell Therapy
Shanghai's Yuesai Biotechnology has become the first company globally to receive IND approval from both the US FDA and China's CDE for an iPSC-derived cell therapy targeting refractory epilepsy, marking a major breakthrough in regenerative medicine.
Chinese Drugmaker Wins FDA Green Light to Test Next‑Generation Obesity Peptide in the US
Shiyao Group has won FDA permission to begin US clinical trials of a long‑acting peptide that acts on both GLP‑1 and GIP receptors for weight management in people with obesity or overweight plus comorbidities. The clearance permits investigational trials but falls short of marketing approval; success would boost China’s ambitions to compete in the lucrative obesity‑drug market dominated by Western firms.
First Inhaled Gene Therapy for Lung Cancer Wins FDA Fast‑Track Nod, Raising Hopes — and Questions
An inhaled gene therapy targeting lung cancer has shown promising early clinical efficacy and received FDA RMAT designation and fast‑track status. The move accelerates regulatory review but leaves open critical questions about safety, durability, manufacturing and who will ultimately benefit.