Diana Ernst

US Food and Drug Administration. FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukemia. October 29, 2024.

The US Food and Drug Administration (FDA) has expanded the approval of Jylamvo (methotrexate) to include the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA).

PP-007 is a unique combination of a carbon monoxide releasing molecule and an oxygen transfer agent.

Topline results were announced from a cardiovascular outcomes study evaluating oral semaglutide in patients with type 2 diabetes.

The Food and Drug Administration (FDA) has expanded the approval of Jylamvo (methotrexate) to include the treatment of pediatric patients with acute lymphoblastic leukemia (ALL), as part of a combination chemotherapy maintenance regimen, and polyarticular juvenile idiopathic arthritis (pJIA).

(fibrin sealant [human]) to include use in pediatric patients as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.

The Food and Drug Administration (FDA) has issued a safety alert regarding the use of Skin-Cap aerosol spray products.

The Food and Drug Administration (FDA) has approved a 420 mg dosage strength of Hercessi ™ (trastuzumab-strf), a biosimilar to Herceptin ® (trastuzumab).

The Food and Drug Administration (FDA) has approved a new presentation of Selarsdi ™ (ustekinumab-aekn), a biosimilar to Stelara ® (ustekinumab), expanding

The Food and Drug Administration has approved Emrosi ™ (minocycline hydrochloride extended-release capsules) for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults.