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 ...

Advances in clinical development keep the hope alive of having new drugs in the not-so-distant future ... capacity and ...

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 ...

Syndax Pharmaceuticals (SNDX) stock dropped ~23% after the company posted Phase 2 trial data for its AML candidate, revumenib ...

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

Google DeepMind releases AlphaFold 3's source code to academics, marking a significant advance in AI-powered molecular biology and drug discovery, while balancing open science with commercial ...

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

Using that new knowledge, they developed a new drug that may counteract the interference and boost ... Inc., and inventors on ...