Aquestive resubmitted its NDA for dibutepinephrine sublingual film Anaphylm, citing new human factors and PK data addressing the FDA's CRL.
News|Videos|March 12, 2025
RX Review: Addressing unmet needs in food allergy diagnosis and care
In part 2 of this 5-part series, panelists discuss confusion in food allergy diagnosis and the need for better medical education.
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In this Contemporary Pediatrics and HCPLive RX Review discussion, moderator Brian Schroer, MD, speaks with Colleen Kraft, MD, and Russell Traister, MD, about unmet needs in research and clinical care.
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FDA approved levacetylleucine (Aqneursa) for ataxia in ataxia-telangiectasia, the first therapy for the disease, in patients 15 kg or heavier.
The FDA granted priority review to efzimfotase alfa for HPP in patients aged 2 years and older; a decision is expected in the first half of 2027.
Adolescent VALIANT subgroup data show pegcetacoplan cut proteinuria 75% vs placebo, supporting its expanded pediatric kidney indication.
The FDA approved Fayuvi (rebisufligene etisparvovec-hopf), a one-time AAV9 gene therapy, as the first treatment for pediatric MPS IIIA (Sanfilippo syndrome type A).
Phase 3 CROSSING trial data show tezepelumab improved histologic remission and dysphagia versus placebo through week 52 in EoE.
FDA approved apitegromab-mstn (Isembyld) for SMA in patients 2 years and up, based on phase 3 data showing added motor gains with SMN2 therapy.
XOCOVA gives pediatricians a new oral option to help prevent COVID-19 after exposure in adolescents aged 12 years and older.
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