The approval of the new citrate-free, high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study.
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Histological remission rates similar with 1-, 6-food elimination diets for adults with eosinophilic esophagitis.
Guideline suggests use of biomarker- and symptom-based monitoring strategy over symptom-based strategy for patients in symptomatic remission.
Study findings suggest targeted inhibition of APOL1 function can reduce proteinuria.
Each capsule contains 140mg of bismuth subcitrate potassium, 125mg of metronidazole, and 125mg of tetracycline hydrochloride.
The table provided is a review of notable updates that occurred in February 2023 for investigational products in development.
Aponvie is an injectable emulsion formulation of aprepitant.
Risk for all-cause, vascular dementia was increased with number of regularly used laxative types
The sNDA is supported by data from the ASSERT study, which included patients less than 17 years old with genetically confirmed Alagille syndrome.
Rebyota is a fecal microbiota suspension for rectal administration.
The application was supported by data from a phase 3 trial that included 330 patients 6 to 17 years of age with functional constipation.
Recently FDA-approved pill, Vibrant, stimulates the colon, causing muscle contractions that move food out
Amjevita is supplied as a 40mg/0.8mL single-dose prefilled SureClick autoinjector, and as 20mg/0.4mL and 40mg/0.8mL single-dose prefilled syringes.
Follow-up colonoscopy rates were 43.3% within 90 days, 56.1% within 360 days of positive stool-based screening test result
Prevalence of advanced neoplasms 40 to 50% lower among those who underwent repeated screening ≥10 years after a negative colonoscopy
The approval was based on data from the phase 2 MOUNTAINEER trial, which included patients with HER2-positive unresectable or metastatic colorectal cancer.
The NDA is supported by two 2 positive interim analyses from the phase 3 REGENERATE trial that included patients with biopsy-proven stage 2 or 3 liver fibrosis due to NASH.
Researchers addressed common misconceptions regarding the diagnosis and treatment of gastroparesis.
Multiple biopsies of duodenum needed for diagnosis of celiac disease; upper endoscopy with intestinal biopsy useful for monitoring cases on gluten-free diet
84.9 percent of 73 patients achieved objective response, including 23.3 percent with complete response