A pipeline of novel drugs awaits FDA review through the first half of 2025 adding significant advances across multiple therapeutic areas, according to an analysis.

Pipeline

1. Deutivacaftor/tezacaftor/vanzacaftor (Vertex): Cystic fibrosis
2. Treosulfan (Medac/Medexus): Stem cell conditioning 
3. Datopotamab deruxtecan (AstraZeneca/Daiichi): Non-small cell lung cancer
4. Vicagrel (Jiangsu Vcare): Peripheral arterial disease/acute coronary syndrome
5. Ensartinib (Xcovery/Betta): Non-small cell lung cancer
6. Garadacimab (CSL Behring): Hereditary angioedema
7. Elamipretide (Stealth BioTherapeutics): Barth syndrome
8. Fitusiran (Sanofi): Hemophilia A and B
9. Tabelecleucel (Atara): Posttransplant lymphoproliferative disorder
10. Sebetralstat (KalVista): Hereditary angioedema
11. Revakinagene taroretcel (Neurotech): Macular telangiectasia
12. Olezarsen (Ionis/Akcea): Familial chylomicronemia syndrome

Two existing therapies are being reviewed for new subcutaneous forms.

1. Nivolumab (Opdivo): Multiple cancers
2. Amivantamab (Rybrevant): NSCLC