The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...

Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.

(HealthDay News) — There is considerable uncertainty regarding the effects of puberty blockers in young individuals experiencing gender dysphoria (GD), according to two reviews published online Jan.

The updated labeling for Qelbree provides additional information on the pharmacodynamic profile of the drug. Findings show ...

The phase 3 LEAP-015 trial evaluated the efficacy and safety of pembrolizumab with lenvatinib in patients with advanced/metastatic gastroesophageal cancer.

The approval of Spravato for the monotherapy indication in TRD was supported by data from the randomized, double-blind, ...

Reports of anaphylaxis associated with the use of glatiramer acetate have prompted the Food and Drug Administration (FDA) to add a Boxed Warning to the prescribing information.

The Food and Drug Administration (FDA) has approved 2 additional vial sizes of Niktimvo ™ (axatilimab-csfr), 9mg/0.18mL and 22mg/0.44mL, in addition to the 50mg/mL size.

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to brelovitug (BJT-778) for the treatment of chronic hepatitis delta (CHD).

In the logistic regression model of the top 20 factors, significant associations for semaglutide initiation included being female (adjusted odds ratio, 2.30), using certain medication classes ...

(HealthDay News) — For patients with resectable esophageal adenocarcinoma, perioperative chemotherapy with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) leads to improved survival ...