US FDA's ODAC members decide potential "life-changing" benefits of Daiichi's proposed rare cancer therapy outweigh liver risks.
The potentially transformative effect of Daiichi Sankyo Co. Ltd.'s proposed rare cancer treatment pexidartinib trumped concerns about liver toxicity and the monitoring that may be required in advisory committee members' minds.
The US Food and Drug Administration's Oncologic Drugs Advisory Committee voted 12-3 that the benefits of pexidartinib outweighed the risks...
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
