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Original-New-Drug-Application-Approvals-by-US-FDA--1-15-May-2025

29 May 2025

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.

Original-New-Drug-Application-Approvals-by-US-FDA--1-15-May-2025

29 May 2025

10-year data reflect teduglutide efficacy for SBS-IF

28 May 2025 bởi

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).

10-year data reflect teduglutide efficacy for SBS-IF

28 May 2025

β-lactam/β-lactamase inhibitor combination noninferior to piperacillin/tazobactam for pneumonia

28 May 2025

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.

β-lactam/β-lactamase inhibitor combination noninferior to piperacillin/tazobactam for pneumonia

28 May 2025

BP medication timing: Bedtime or daytime, the effect’s the same

27 May 2025 bởi

For adults with hypertension being treated in the primary care setting, taking their blood pressure (BP)-lowering medications at bedtime is safe but confers no additional cardiovascular protection as opposed to taking them in the morning, according to the results of the BedMed trial.

BP medication timing: Bedtime or daytime, the effect’s the same

27 May 2025

Antiviral therapy lowers HCC risk in indeterminate CHB phase

27 May 2025 bởi

Patients with chronic hepatitis B (CHB) in the indeterminate phase are predisposed to advanced liver disease and hepatocellular carcinoma (HCC), as shown by a systematic review and meta-analysis.

Antiviral therapy lowers HCC risk in indeterminate CHB phase

27 May 2025

$Testosterone offers no long-distance mobility benefit to women with hip fracture$

Testosterone offers no long-distance mobility benefit to women with hip fracture

27 May 2025

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.

Testosterone offers no long-distance mobility benefit to women with hip fracture

27 May 2025

Seladelpar improves cholestatic, liver injury markers in patients with PBC, cirrhosis

27 May 2025 bởi

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.

Seladelpar improves cholestatic, liver injury markers in patients with PBC, cirrhosis

27 May 2025

Etrasimod shows promise in eosinophilic oesophagitis

26 May 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.

Etrasimod shows promise in eosinophilic oesophagitis

26 May 2025

Superior IBD control achieved with biomarker-guided therapy standard care

26 May 2025 bởi

Biomarker-informed molecular guidance improves anti-TNF therapy outcomes in patients with inflammatory bowel disease (IBD), increasing the likelihood of achieving disease control when compared with standard “best care,” as shown in the GUIDE-IBD trial.

Superior IBD control achieved with biomarker-guided therapy standard care

26 May 2025

Investigational Gal3 inhibitor NAVIGATEs MASH treatment field

26 May 2025 bởi

The galectin-3 (Gal3) inhibitor belapectin, given at the established 2-mg dose, demonstrates its treatment potential for metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension (PH) in the phase IIb/III NAVIGATE trial.

Investigational Gal3 inhibitor NAVIGATEs MASH treatment field

26 May 2025

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Original-New-Drug-Application-Approvals-by-US-FDA--1-15-May-2025

Original-New-Drug-Application-Approvals-by-US-FDA--1-15-May-2025

10-year data reflect teduglutide efficacy for SBS-IF

10-year data reflect teduglutide efficacy for SBS-IF

β-lactam/β-lactamase inhibitor combination noninferior to piperacillin/tazobactam for pneumonia

β-lactam/β-lactamase inhibitor combination noninferior to piperacillin/tazobactam for pneumonia

BP medication timing: Bedtime or daytime, the effect’s the same

BP medication timing: Bedtime or daytime, the effect’s the same

Antiviral therapy lowers HCC risk in indeterminate CHB phase

Antiviral therapy lowers HCC risk in indeterminate CHB phase

Testosterone offers no long-distance mobility benefit to women with hip fracture

Testosterone offers no long-distance mobility benefit to women with hip fracture

Seladelpar improves cholestatic, liver injury markers in patients with PBC, cirrhosis

Seladelpar improves cholestatic, liver injury markers in patients with PBC, cirrhosis

Etrasimod shows promise in eosinophilic oesophagitis

Etrasimod shows promise in eosinophilic oesophagitis

Superior IBD control achieved with biomarker-guided therapy standard care

Superior IBD control achieved with biomarker-guided therapy standard care

Investigational Gal3 inhibitor NAVIGATEs MASH treatment field

Investigational Gal3 inhibitor NAVIGATEs MASH treatment field