The FDA has told Incyte that it can’t review the company’s new drug application (NDA) for Janus kinase inhibitor Jakafi (ruxolitinib) extended-release (XR) tablets without more supporting data. Read More

Sponsors of new oncology drugs and biologics that aim to apply for Accelerated Approval (AA) should use a randomized controlled trial (RCT) design rather than a single-arm trial in most cases, the FDA advises in new draft guidance issued last week. Read More

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed major reforms to its clinical trial regulations — including a 30-day maximum for reviewing new trial applications and a 10-day maximum for granting a decision after receiving requested follow-up information. Read More

The FDA said it could not approve AbbVie’s new drug application (NDA) for ABBV-951 (foslevodopa/foscarbidopa), an investigational therapy for advanced Parkinson’s disease, because of concerns about the delivery device. Read More

The Federal Trade Commission (FTC) has filed an amicus brief urging the U.S. District Court for the District of Delaware not to dismiss the suit brought by Sage Chemical and its marketing partner TruPharma against Supernus Pharmaceuticals over alleged blocking of generic competition. Read More

The FDA is standing up a new program to provide a framework for regulators, researchers and the public to explore how digital health technologies (DHT) — such as mobile medical apps and wearable devices — can advance drug development. Read More