On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic bre
The FDA has approved a new small molecule inhibitor from Celcuity with blockbuster potential that could become a new standard-of-care for patients with breast cancer.
Certain delivery systems that are used to insert a pulmonary valve have an increased risk of distal tip detachment, the company said. The valve itself is not affected by the recall.
After pausing a controversial policy to publicly release drug rejection letters in April, the FDA today confirmed that the pause has been lifted and that more documents will be coming down the line.
Matching the right patient to the right therapy now requires understanding what’s driving the apnea, not just how often it occurs. Closing that gap means rethinking what sleep apnea testing identifies and where it happens. The post Why the Next Era of Sleep Medicine Depends on Better Diagnostics appeared first on MedCity News .
It usually tracks some version of value delivered, where more customers lead to more usage and more revenue. However, in healthcare, the blind pursuit of revenue can cause real harm. The post Revenue Is a Misleading KPI in Healthcare appeared first on MedCity News .
This privacy notice describes how we collect and use your personal information, in accordance with the Data Protection Act and the General Data Protection Regulation.
Biogen leaders took to an investor call today to defend the phase 2 readout of the company’s anti-tau Alzheimer’s disease candidate, which, despite slowing cognitive decline on par with approved medicines, sparked a significant stock slip.
In this interview, W. Douglas Weaver MD, MACC and Deepak Bhakta, MD, MBA, FACC discuss managing subclinical AFib detected by devices, ambulatory monitors and wearables.
The PBM reform efforts are directional, not temporary. Meeting these expectations requires automated systems that can reconstruct claim logic on demand and provide real-time alignment between pricing, rebates and financial outputs. The post Pharmacy Benefit Operations Infrastructure Must Rise to Regulatory Reform Standards appeared first on MedCity News .
The 2026 Care of the Athletic Heart was a 1-day preconference held in advance of the American College of Cardiology Annual Scientific Session. The session, hosted by Dr. Jeffrey Hsu, welcomed guests from over 14 countries and aimed to deliver focused, practical updates in sports cardiology, while providing education and insight into this rapidly evolving field.