The FDA has started a priority review of GSK's gepotidacin, which could become the first in a new class of oral antibiotics for uncomplicated urinary tract infections (uUTIs) in over 20 yea
Zealand Pharma has suffered another setback in its bid to bring glucagon receptor agonist dasiglucagon for ultra-rare disease congenital hyperinsulinism (CHI) to the US market.
Generative AI (GenAI) technology is already transforming everyday regulatory and safety processes, thanks to its ability to digest, assess, and summarise key insights and findings from acro
Medical, legal and regulatory review (MLR review) of promotional as well as non-promotional materials is one of the core responsibilities of medical and commercial teams within any life sci