FDA grants fast track status for Merrimack’s pancreatic cancer drug MM-398
Currently, the company is preparing a new drug application (NDA) for MM-398 in the US to treat these patients with metastatic pancreatic cancer. The FDA fast track status
The US Food and Drug Administration (FDA) has approved Pfizer’s Tukysa (tucatinib) along with pertuzumab and trastuzumab as a maintenance therapy for breast cancer.
The NDA was based on an international, randomized, multicenter, double-blind, relapse prevention Phase III trial of paliperidone palmitate three-month injection. More than 500 patients were included in the
According to FDA, all currently enrolled patients can continue receiving aldoxorubicin treatment, or comparator drugs, as per study protocols. Additionally, the company cannot enrol new patients until the
Created by Atlas Venture and Caribou Biosciences, together with leading scientists who have pioneered and shaped the field of CRISPR biology, Intellia leverages exclusive access to one of
The collaboration will focus on new therapeutic approaches for the treatment of various acute neurological conditions resulting from neurovascular instability. This discovery collaboration brings together Edge’s scientific expertise