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 approves Teva Pharmaceutical Industries AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, a combination t...
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Federal Register notice: FDA makes available a draft guidance entitled Population Pharmacokinetics (PK) to assists sponsors in applying PK during drug...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.
Federal Register notice: FDA releases a draft guidance on Hormonal Contraceptive Drug Product Development.