The newly appointed members of the European Medicines Agency’s New Approach Methodologies Operational Expert Group are drawn ...

OH and MGPI Schedule I controlled substances when either one alone, or combined, exceeds 1mg per gram in solid products or ...

Bausch + Lomb board chairman and Bausch Health CEO Thomas Appio has been appointed interim CEO effective immediately. Bausch ...

LigIT.AI and Nutshell Therapeutics raise new funding for the development of oral cyclic peptides and allosteric drugs, ...

The LPA1 antagonist would add a new mechanism of action to idiopathic pulmonary fibrosis treatment if approved, but questions ...

Humotech’s mobile clinic lets amputees try out prosthetic feet via a robotic system without knowing which model they are ...

A new analysis tracks how the EU’s clinical research environment has evolved over more than a decade, amid a new regulatory ...

The US FDA has issued an early alert concerning connectivity issues with the Philips Lumify ultrasound system that may ...

A notice seeking public input now under Office of Management and Budget review suggests the FDA wants to consolidate its ...

Pharmaceutical companies need to give more clarity about what they would provide in return for higher drug prices.

After a slower beginning of the calendar year, NDA and BLA approval activity jumped in July, August and September, which pushed its averages back to historical norms.

The National Health Service (NHS) in England will pilot whether easing local affordability pressures can turn NICE approval ...