Tin tức & Cập nhật

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.

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.

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 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.

Use of dolutegravir (DTG) proves to be effective and safe in children and adolescents living with HIV (CALHIV) in low- and middle-income countries (LMICs), as shown in a study.