for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 ("GDUFA”) goal date of October 29, 2024. On November 12, 2024, the FDA granted the ...

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 ...

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

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

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

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

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

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

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

Former President Donald Trump has boasted in recent months about "Right To Try," a law he signed in 2018. It's aimed at ...

Harry may come to rue the day he revealed how he had talked to a toilet while high on magic mushrooms at Courteney Cox’s ...

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