Federal Register notice: FDA seeks comments on an information collection extension for its guidance on Notification of the Intent To Use an Accredited...
FDA approves a ViiV Healthcare NDA for Juluca, the first complete treatment regimen containing two drugs to treat certain adults with human immunodefi...
Stakeholders ask FDA for greater clarification on elements in its proposed framework for drug benefit-risk analysis.
The House Commerce Subcommittee on Health announces an 11/30 hearing on Implementing the 21st Century Cures Act: An Update from FDA and NIH.
Three industry representatives take different approaches to FDA efforts to restore a balance between innovation and generic drug accessibility.
FDA warns Chinas Hubei Pharmaceutical Co. about CGMP violations in its production of active pharmaceutical ingredients.
Genentech says a Pfizer biosimilar to its Herceptin will infringe 40 Genentech patents and should be barred by a federal court injunction until the pa...
A new White House report estimates that the ongoing opioid crisis cost the U.S. $504 billion in 2015 and led to over 33,000 American overdose deaths.