Sunvozertinib has shown promising results in patients with non–small cell lung cancer with an EGFR exon 20 insertion mutation ...

The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...

The US FDA has cleared an investigational new drug (IND) application for HG202, by HuidaGene Therapeutics. This drug is the ...

AstraZeneca’s earnings were boosted by its oncology, cardiovascular, respiratory and immunology (R&I), and rare disease ...

The path from a scientist’s initial idea to a new medicine that can save lives is a complex and often lengthy process. It ...

must submit an NDS within 12 months of filing a New Drug Application (NDA) in the US. This requirement is established by ...

While A.I. promises breakthroughs, industry leaders warn that transparency and patient safety must remain front and center.

AstraZeneca Plc raised its annual forecast, driven by strong demand for its blockbuster cancer drugs, and revealed a plan to ...

If Kevin Roberts, the author of the extreme conservative Project 2025 “blueprint” for a second Trump term, is granted an ...

Medical experts who’ve studied the experimental treatment program, however, say there’s no evidence to support Trump’s claims ...

The FDA previously granted donidalorsen Orphan Drug Designation ... Application (MAA) to the European Medicines Agency (EMA) this year. Ionis recently presented new results from the Phase ...

Excitement is building around a new weight loss drug, CagriSema, which is expected to surpass the effects of popular drugs ...