{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T10:11:34Z","timestamp":1788948694175,"version":"build-2803163510"},"reference-count":116,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T00:00:00Z","timestamp":1788912000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Antibiotics"],"abstract":"<jats:p>The rise of multidrug-resistant (MDR) pathogens in the pediatric population represents a significant global health challenge, compounded by a historically stagnant antibiotic pipeline for children. While several novel antibiotics have been approved for adults in recent decades, pediatric labeling is often deferred due to the complexities of developmental pharmacology and due to a certain precautionary prudence in introducing new drugs onto the market for this population. This review explores the landscape of the most recent antibiotics, including advanced cephalosporins (ceftaroline, cefiderocol, and ceftobiprole), novel beta-lactam\/beta-lactamase inhibitor combinations (e.g., ceftazidime\/avibactam, meropenem\/vaborbactam), and long-acting lipoglycopeptides. We analyze their approval trials, pediatric-specific PK\/PD profiles, and the balance between on-label use and evidence-based off-label prescriptions. Furthermore, we emphasize the role of antimicrobial stewardship through the \u201c3 D\u2019s\u201d rule and the evolution of Therapeutic Drug Monitoring (TDM) from reactive safety controls to proactive, model-informed precision dosing (MIPD). Finally, we advocate for a multidisciplinary synergy between pediatricians and pharmacologists as the cornerstone for optimizing outcomes and preserving the efficacy of the future antibiotic pipeline.<\/jats:p>","DOI":"10.3390\/antibiotics15090883","type":"journal-article","created":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T09:24:02Z","timestamp":1788945842000},"page":"883","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Stewardship Challenges, PK\/PD Evidence, and Prescribing Appropriateness for Recently Approved Antibiotics in Pediatric Practice"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9150-425X","authenticated-orcid":false,"given":"Alessandra","family":"Romandini","sequence":"first","affiliation":[{"name":"Clinical Pharmacology Unit, Chemical-Clinical Analyses Laboratory, A.S.S.T Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3633-4080","authenticated-orcid":false,"given":"Chiara","family":"Resnati","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Unit, Chemical-Clinical Analyses Laboratory, A.S.S.T Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefania","family":"Crucitta","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Unit, Chemical-Clinical Analyses Laboratory, A.S.S.T Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9765-5529","authenticated-orcid":false,"given":"Stefano","family":"Agliardi","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Unit, Chemical-Clinical Analyses Laboratory, A.S.S.T Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7825-4922","authenticated-orcid":false,"given":"Federico","family":"D\u2019Amico","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Unit, Chemical-Clinical Analyses Laboratory, A.S.S.T Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia Angela Carla","family":"Pattarino","sequence":"additional","affiliation":[{"name":"Division of Pediatrics, A.S.S.T Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Altieri","sequence":"additional","affiliation":[{"name":"Division of Pediatrics, A.S.S.T Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Romano","family":"Danesi","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Unit, Chemical-Clinical Analyses Laboratory, A.S.S.T Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy"},{"name":"Oncology & Onco-Hematology Department, Universit\u00e0 degli Studi di Milano, 20162 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Costantino","family":"De Giacomo","sequence":"additional","affiliation":[{"name":"Division of Pediatrics, A.S.S.T Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,9,9]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Romandini, A., Pani, A., Schenardi, P.A., Pattarino, G.A.C., De Giacomo, C., and Scaglione, F. 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