News

Targeted Oncology17h
FDA BLA Pulled for Patritumab Deruxtecan in EGFR+ NSCLC
The FDA biologics license application for patritumab deruxtecan in EGFR+ NSCLC has been withdrawn following discussions with ...
Targeted Oncology3d
FDA Clears IND for EGFR/HER3 Bispecific ADC AVZO-1418/DB-1418
The FDA cleared an investigational new drug application for AVZO-1418/DB-1418, and a phase 1/2 trial in advanced solid tumors ...
FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation
The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded ...
Center for Biosimilars2d
FDA Approves Starjemza as New Stelara Biosimilar
Starjemza gains FDA approval as the eighth ustekinumab biosimilar, enhancing treatment options for rheumatic and gastrointestinal conditions.
Healio10d
FDA nudges development of drug to prevent necrotizing enterocolitis
The FDA recently granted orphan drug and rare pediatric disease designations to Infinant Health for a live biotherapeutic ...
Healio9d
FDA Recap: April, May big months for intervention, electrophysiology approvals
Recent FDA updates in the areas of cardiac intervention, hypertension and arrhythmia disorders expand the pool of available ...
CURE9d
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 ...