Daraxonrasib, a new pancreatic cancer drug, cut the risk of death by 60% in a Phase 3 trial. A doctor explains how it works, ...

Gedatolisib targets HR+/HER2-, PIK3CA wild-type advanced breast cancer, with a PDUFA goal date of July 17, 2026. The drug's multi-target approach inhibits all four class 1 PI3K isoforms, mTORC1, and ...

This approval provides patients with a new generic option for the folate analog metabolic inhibitor, which is used to treat ...

Belite expects to complete the new drug application submission in the second quarter of 2026Rolling submission initiated under Breakthrough ...

Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being ...

Antibody drug conjugates have cemented their place among the treatment options for many cancers, but one problem with this type of targeted therapy is drug resistance. The scientists at Fortitude ...

A growing body of research has examined the IRA’s implications for pharmaceutical innovation. Much of this literature has focused on the potential impact on the number of new drug launches, 5, 6 but ...

This FDA Acceptance is a Milestone for People Living with Narcolepsy Type 1 Who Need New and Different Treatment Options Oveporexton is an Orexin Agonist Designed to Restore Orexin Signaling and ...

--If approved, adrabetadex would be the only therapy to directly target the underlying pathophysiology of Niemann-Pick disease type C (NPC) --Comprehensive NDA application includes data showing ...

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ulixacaltamide HCl for the treatment of essential tremor in adults. Ulixacaltamid ...

FDA assigns PDUFA target action date in the third quarter of calendar year 2026 with launch expected at the end of September 2026 Priority Review supported by positive Phase 3 VALOR results, the first ...