FDA clears a Spirosure 510(k) for its Fenom Pro Asthma Monitor for use by allergists, immunologists and pulmonologists to help patients manage asthma ...
Macleods Pharmaceuticals recalls one lot of losartan potassium/hydrochlorothiazide 100mg/25mg combination tablets due to an impurity level concern.
A new FDA safety alert warns about Pfizers tofacitinib (Xeljanz, Xeljanz XR) after a clinical trial found an increased risk of blood clots in the lung...
FDA Review posts the Federal Register notices for the week ending 2/22/2019.
FDA Review posts product approval summaries for the week ending 2/22/2019.
An FDA drug safety review concludes that an increased risk of death exists with Takedas Uloric (febuxostat) compared to another gout medicine, allopur...
Federal Register notice: FDA makes available a draft guidance entitled Smoking Cessation and Related Indications: Developing Nicotine Replacement Ther...
FDA approves changes to the prescribing information for Pfizers Chantix (varenicline) that specifies that the drug is not recommended for pediatric pa...