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New drug applications approved by US FDA as of 16-30 June 2023 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
Adults with hypertension, diabetes, and cardiovascular diseases may benefit from cutting back on coffee, especially the caffeinated variant, which has been shown to increase the burden of abdominal aortic calcification in a study.
The ileal bile acid transporter (IBAT) inhibitor maralixibat appears to quell itching and reduce serum bile acid concentration in children with progressive familial intrahepatic cholestasis (PFIC), while having a tolerable safety profile, according to data from the phase III MARCH-PFIC trial said to be the largest to date.
Implementation of the mandate on preablation renal mass biopsy appears to result in the wider use of biopsies for all small renal mass patients, fewer surgical interventions, and an increase in active surveillance, reports a recent study.
Treatment with pembrolizumab (pembro) in combination with gemcitabine and cisplatin (gem/cis) results in a statistically significant, clinically meaningful improvement in overall survival (OS) when compared with placebo plus gem/cis in patients with previously untreated metastatic or unresectable biliary tract cancer (BTC), results of the KEYNOTE-966 study have shown.
Sleep disorders, particularly obstructive sleep apnoea, are associated with a higher risk of sexual dysfunction (SD) in both men and women, suggests a study.
In a pooled analysis of two long-term paediatric extension trials evaluating short bowel syndrome-associated intestinal failure (SBS-IF), the glucagon-like peptide-2 analogue teduglutide (TED) demonstrated a safety profile that aligned with previous data.
For patients with chronic kidney disease (CKD), vitamin D therapy does little to reduce the risk of all-cause death, according to a study.
For adolescents with treatment-refractory irritable bowel syndrome (IBS), faecal microbiota transplantation (FMT) is safe and beneficial, easing abdominal pain and improving health-related quality of life, according to a study presented at ESPGHAN 2023.
Treatment with fractional CO2 laser is both safe and effective for women suffering from vestibular pain, as shown in a recent study.
