OR WAIT null SECS
September 08, 2015
The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.
September 02, 2015
Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.
July 21, 2015
A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.
June 18, 2015
The agency streamlines risk and mitigation information.
The agency publishes guidance on the physical attributes of generic tablets and capsules.
June 10, 2015
An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).
May 29, 2015
The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.
May 26, 2015
Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.
May 12, 2015
The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.
May 08, 2015
Novartis announces that its lung cancer drug, Zykadia, gained European Union approval.