FDA approves Bausch + Lombs Ultra contact lenses for extended wear for up to six nights and seven days of continuous wear.
Biocon says an FDA-483 issued following an inspection at its Bangalore, India, sterile drug manufacturing facility has seven observations.
Fresenius says its decision last month to terminate the companys $4.7 billion merger agreement with generic drug company Akorn was based on alleged bl...
FDA approves a Medtronic PMA for its Deep Brain Stimulation therapy as adjunctive treatment for reducing the frequency of partial-onset seizures.
Attorney Jonah Knobler says that plaintiff attacks on the learned intermediary doctrine may be running out of steam, based on a 7th Circuit decision i...
Karyopharm Therapeutics says it will submit an NDA in the second half of this year for selinexor for multiple myeloma after reporting positive top-lin...
FDA clears a Conavi Medical 510(k) for its Novasight Hybrid System, which allows simultaneous imaging of coronary arteries with both intravascular ult...
FDA approves a Novartis NDA for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of certain patients with me...