A new study finds that FDA tends to be more restrictive than its advisory committees when approving new products, new supplemental indications and new...
FDA declines to approve an AstraZeneca supplemental NDA for Farxiga (dapagliflozin) as an adjunct treatment to insulin to improve glycemic control in ...
FDA clears a LivaNova 510(k) for its LifeSPARC system, a new circulatory support pump and controller, intended for use in providing temporary support ...
FDA approves an Abbott PMA for its fourth-generation MitraClip, a heart valve repair device to treat mitral regurgitation.
FDA Review posts product approval summaries for the week ending 7/12/2019.
Federal Register notice: FDA makes available a draft guidance entitled Population Pharmacokinetics (PK) to assists sponsors in applying PK during drug...
Altaire Pharmaceuticals recalls numerous brands of over-the-counter eye drops sold at CVS Health due to sterility concerns.