News

CURE1d
FDA Grants Fast Track Designation to ZL-1310 in Small Cell Lung Cancer
ZL-1310 earns fast track designation in extensive-stage small cell lung cancer after early trial data showed tumor shrinkage ...
Clinical Trials Arena2h
Navigating the FDA’s accelerated approval pathways for oncology drugs
At CTO West Coast, an expert discussed the implications of the FDA’s expedited approval programmes with a spotlight on ...
Zai Lab gets FDA fast track status for lung cancer treatment
Zai Lab Limited (NASDAQ:ZLAB) said on Monday that it received U.S. FDA fast track designation for its antibody-drug conjugate ...
Zai Lab Limited: Banking On Chinese Pharma Growth
Zai Lab Limited gains momentum with FDA Fast Track nod and solid earnings, signaling growth potential. Click here to find out ...
NC Biotech8d
FDA gives Fast Track designation to Incyclix Bio's ovarian cancer treatment
The U.S. Federal Drug Administration (FDA) has granted Incyclix Bio Fast Track designation for INX-315 to treat ...
pharmaphorum4d
FDA fast-tracks Merck's cancer blockbuster-in-waiting
Evofosfamide already has fast-track status in the US as a treatment for soft tissue sarcoma (STS) and – if approved by the FDA – could quickly generate sales in excess of $1 billion in each ...
Oncology Nursing News9d
Fast Track Status Given to ADRX-0706 for Squamous Cell Cervical Cancer
ADRX-0706 has received FDA fast track designation for the treatment of metastatic or locally advanced squamous cell cervical ...
NC Biotech2d
FDA grants RMAT designation to Atsena’s gene therapy for rare eye disease
Durham-based Atsena Therapeutics has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for ATSN-201, its gene therapy product for the ...