Researchers say that pivotal trials based on non-continuous surrogate markers often exaggerate treatment effects.
FDA releases a draft guidance and in-effect compliance guide on postmarket safety reporting for combination products.
FDA warns Indias Malladi Drugs & Pharmaceuticals about CGMP deviations in its manufacturing of API.
Researchers from three universities say it should be possible to design a safe system through which Americans could obtain off-patent drugs manufactur...
MarketWatch says drug companies fear that new co-pay accumulator initiatives will lower their sales as patients look for lower-cost alternatives.
A Massachusetts state court says a plaintiff may amend one element of his complaint against Merck alleging intentional failure to update the Proscar l...
FDA clears a Restoration Robotics 510(k) to expand the Artas hair restoration technology to include robotic implantation.
FDA accepts for priority review a Pfizer and Astellas Pharma supplemental NDA for Xtandi (enzalutamide) for an expanded indication to include men with...