In response to a request for information from the White House, PhRMA has offered recommendations for improving clinical trial infrastructure to enable effective responses to public health emergencies, including advice…
Dunagin Pharmaceuticals of Rogers, Ark., received an FDA warning letter for manufacturing drugs on the same equipment used to manufacture non-drug products and failing to test samples of product components…
Members of an FDA advisory committee agreed in a 5-3 vote yesterday that clinical data on Biogen’s tofersen — a first-in-class drug candidate for a rare type of amyotrophic lateral sclerosis…
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. Source:…
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…
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…
To disrupt the high-cost insulin market, the state of California is teaming up with nonprofit generic drug manufacturer Civica Rx to make insulins that will become available at low cost.…
The Pharmaceutical Research and Manufacturers of America (PhRMA) is asking for several changes to the FDA’s January draft guidance on the dosage and administration section of labeling for drugs and…
The FDA appears to be casting a favorable eye on Biogen’s SOD1-amyotrophic lateral sclerosis drug tofersen, suggesting that reductions in neurofilament light, a protein associated with neuronal damage, could support…
Insurers need more evidence of long-term safety and efficacy to make the best decisions about whether — and how — to cover Eisai’s Leqembi (lecanemab) for early Alzheimer’s disease, according…