The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Vanda Pharmaceuticals regarding the New Drug Application (NDA) for tradipitant for the treatment of gastroparesis.
The over-the-counter medical application is intended for individuals aged 18 years and older who have not been previously diagnosed with sleep apnea.
Following an inspection by the FDA, it was revealed that there was significant microbial contamination in 1 lot of SnoreStop Nasal Spray.
Safety profile similar to other trials, with six in 10 sustaining medication overuse headache remission over six months ...
HealthDay News — The demand for psilocybin-assisted therapy (PSIL-AT) for major depressive disorder (MDD) and treatment-resistant depression (TRD) varies from 24 to 62 percent depending on the ...
Reduced risk for Alzheimer disease, vascular dementia, and Parkinson disease seen with SGLT2i use in type 2 diabetes.
Findings showed a noninferior immune response for both vaccines when Shingrix and Arexvy were coadministered compared with separate administration (primary endpoint). Both anti-gE antibody ...
IPF is a rare progressive fibrosing interstitial lung disease with symptoms that include breathing difficulty, dry and persistent cough, chest discomfort and fatigue. The randomized, double-blind, ...
The Food and Drug Administration (FDA) has approved Fasenra ® (benralizumab) for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
The FDA has approved Kisqali (ribociclib) in adults with HR-positive, HER2-negative stage II and III early breast cancer.
In a recent study, one dose of modified vaccinia Ankara-Bavarian Nordic vaccine had estimated vaccine effectiveness of 58%.
HealthDay News — For postoperative patients with breast cancer, the duration of aromatase inhibitor (AI) treatment is not associated with the risk for coronary artery calcium (CAC), according to a ...