FDA grants three-month review extension for Exelixis' metastatic colorectal cancer candidate
read at Endpoints ↗RegulatoryNeutral
Exelixis, a California drug developer, has provided the FDA with additional safety and efficacy data for its experimental therapy aimed at treating metastatic colorectal cancer.
The agency responded by extending the review period by three months, giving the company more time to address outstanding questions.
The extension does not constitute an approval, but it keeps the candidate in the regulatory pipeline while further data are evaluated.
source
This writeup was produced by pharmadog from original reporting by Endpoints.
Original headline: “FDA extends review of Exelixis' colorectal cancer drug candidate”
read at Endpoints ↗80 words · retrieved Sep 11
comments(0)
5-min edit window · permanent after that