[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Allergy Laboratories, Blueshine/Hyperion Medical, Shoney Scientific India, Synec...[ Price : $8.95]
FDA warns Wockhardt about CGMP violations at two plants in India similar to those in an earlier Warning Letter.[ Price : $8.95]
A new CDER strategic plan outlines four major strategies the Center plans to pursue smarter regulation, scientific innovation, le...[ Price : $8.95]
FDA approves a new warning on Lundbecks anti-seizure drug Onfi (clobazam) about rare but serious skin reactions that can result in...[ Price : $8.95]
Actelion says a data monitoring committee recommended ending the DUAL-2 study of macitentan in patients with systemic sclerosis an...[ Price : $8.95]
GlaxoSmithKline asks FDA to make changes in its draft guidance on standards for generic versions of the companys Advair Diskus dry...[ Price : $8.95]
The National Kidney Foundation again urges FDA to assign unique nonproprietary names to biosimilars, including those that are cons...[ Price : $8.95]
FDA clears a Cochlear Limited 510(k) for the Cochlear Baha 4 Attract System, a direct bone conduction hearing device.