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DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions
The
third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the
FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds
It has been a turbulent year for the US
Food and Drug Administration (FDA), marked by reduction
Top first-in-class drug candidates of 2025: Ionis’ donidalorsen, Sanofi’s fitusiran, Cytokinetics’ aficamten await FDA approval
First‑in‑class drugs are therapies with entirely new approaches that improve patient out
FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies
In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though
