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New drug applications approved by US FDA as of 16-30 April 2025 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.

New drug applications approved by US FDA as of 1-15 May 2025 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.

An interim analysis of a real-world study reporting up to 10 years of follow-up data shows that teduglutide, a human glucagon-like peptide-2 analogue, can provide long-term reductions in parenteral nutrition and/or intravenous fluid (PN/IV) requirements and shorter time to achieve enteral autonomy in adults with short bowel syndrome-associated intestinal failure (SBS-IF).

In the treatment of adults with hospital-associated (HABP) or ventilator-associated bacterial pneumonia (VABP), the β-lactam/β-lactamase inhibitor combination imipenem/cilastatin/relebactam appears to be as good as piperacillin/tazobactam, with similar safety profiles, according to a phase III trial.

Use of topical testosterone therapy in addition to supervised exercise training does little to improve long-distance walking ability for older women recovering from a hip fracture, according to the phase III STEP-HI randomized clinical trial.

Treatment with seladelpar led to improvements in markers of cholestasis and liver injury in patients with primary biliary cholangitis (PBC) and compensated cirrhosis, according to an additional analysis of the RESPONSE trial presented at DDW 2025.

In the treatment of eosinophilic oesophagitis, the use of etrasimod is well tolerated and results in sustained histological and endoscopic improvements and symptom reduction, according to the results of a phase II study.