Prometic Biotherapeutics

The US and the EU both posted impressive numbers of novel approvals in the first half of 2021, but with little overlap. Only three of the 32 new molecular entities and novel biologics authorized by th

Serious concerns about manufacturing quality extended the US Food and Drug Administration’s fast-track review of Prometic Biotherapeutics Inc.’s designated orphan drug, Ryplazim (plasminogen, human-

The US FDA’s Center for Biologics Evaluation and Research took only half of 2021 to match its novel approval count for all of 2020, issuing its fifth approval of a new biologic this year on 15 June to

The US Food and Drug Administration is starting off the summer with an array of approvals in historically less-active development areas like women’s health and obesity – along with the ninth novel onc