After greenlighting 56 novel therapeutics in 2025, four notable applications continue to await the agency’s action after ...

Sevabertinib, targeting HER2 and EGFR mutations, received FDA breakthrough designation for HER2+ NSCLC, showing a 59% overall ...

Swedish neurotech startup Flow Neuroscience has secured FDA approval for the first brain stimulation device for home use in ...

The US FDA has approved mosunetuzumab-axgb (Lunsumio VELO) as a subcutaneous formulation for the treatment of adult patients ...

Abstract: Machine learning has been successfully applied to drug combination prediction in recent years. However, in some situations, the class imbalance problem still shows highly negative impacts on ...

The FDA Biomarker Qualification Program approved changes in hip bone mineral density (BMD) after treatment to serve as a surrogate endpoint in place of bone fractures in anti-osteoporosis drug ...

President Donald Trump signed an executive order Thursday reclassifying marijuana as a less dangerous drug — a move expected to ease restrictions so it's easier to purchase and sell, and pave the way ...

Shares drop after FDA delays decision on tolebrutinib drug Late-stage trial shows drug fails to slow disability progression Analysts fret over Sanofi drug pipeline and investor confidence Dec 15 ...

(RTTNews) - Milestone Pharmaceuticals Inc. (MIST) is awaiting a pivotal U.S. FDA decision this month on the company's lead drug candidate, CARDAMYST nasal spray, for the acute treatment of paroxysmal ...

Company engaging in multiple options for a constructive resolution Strategy is underpinned by a clinical study that achieved the agreed upon endpoints Company believes that labeling modifications can ...