Operator Welcome to Amarin Corporation's conference call to discuss its fourth-quarter and full-year 2024 business update and ...

A system-focus is particularly relevant for generic manufacturers and given that the new pharmacovigilance legislation enables the EMA to charge ... in drug safety, regulatory affairs, medical ...

Exploring Regulatory Affairs, the discipline dedicated to ensuring that new drugs and biologics are safe, effective, and ...

These two books present vivid accounts of right-wing movements that seek to undermine the modern regulatory state, or what conspiracists call “the deep state.” Until recently, a capable government ...

and the company’s work with regulatory authorities. Pharmaceutical Executive: DB-OTO has received multiple designations from the FDA and EMA—how do these designations accelerate the development and ...

“Together with the US FDA orphan designation, the positive opinion from the EMA represents an important step towards this significant regulatory milestone for the company in Europe and positions ...

Edvardsen previously served in several senior roles, most recently as chief development officer for Nykode Therapeutics, overseeing regulatory affairs, clinical development ... with securing the ...

Drawing on utilitarian calculations of costs and benefits, the book develops a logic of obligations over space and time: wealthy countries owe much to poorer ones, just as the current generation owes ...

“Our mission is to turn innovative science into value for patients and we are working in a lot of different areas with high unmet need,” says Stef Schutte, Astellas’ head of regulatory affairs.