Panel Endorses Samska, Infers Clinical Benefit For The Hyponatremia Drug
An FDA advisory panel endorsed Otsuka Pharmaceuticals' Samska (tolvaptan) for hyponatremia June 25 even though the sponsor's post-hoc analysis of a surrogate endpoint did not clearly prove the drug's clinical benefit
More from Archive
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’