Drug Pipeline News

FDA approved Tylenol with Naproxen, the first OTC fixed-dose acetaminophen/naproxen sodium tablet, for 12-hour pain relief in patients 12 and older.

A pooled ADORING trial analysis found tapinarof cream improved skin clearance by week 2 across ages 2 through adulthood in atopic dermatitis.

Udenafil lowered ELF scores after 12 months in an exploratory Fontan substudy, but liver stiffness measures did not significantly change.

The FDA granted priority review to obinutuzumab for relapsing/steroid-dependent pediatric INS, based on phase 3 INShore remission data

FDA accepted BioMarin's sNDA to convert vosoritide's achondroplasia indication to full approval, with a PDUFA date of February 28, 2027.

Tralokinumab showed expected pharmacokinetics and no new safety findings in 28 children with moderate-to-severe atopic dermatitis.

A matched cohort study found no meaningful difference in serious or outpatient infection risk between infliximab and adalimumab in pediatric IBD.

VCA-894A received FDA rare pediatric disease designation for CMT2S, an ultrarare inherited neuropathy with limited treatment options.

Tegacorat received FDA orphan drug and rare pediatric disease designations for Duchenne muscular dystrophy.

Saol resubmitted SL1009 to the FDA for PDCD after added survival analyses, with no new clinical trial reported.

FDA expanded wilate's label to routine prophylaxis in VWD patients aged 6 and up, based on phase 3 WIL-31 data showing an 84% drop in bleeding rate.

If approved, the expanded indication would make roflumilast cream 0.05% the first once-daily, steroid-free topical PDE4 inhibitor approved specifically for this age group.

FDA cleared an IND for a NCATS-sponsored AAV9/SUMF1 gene therapy in multiple sulfatase deficiency, moving the ultra-rare disease toward its first-in-human trial.

FDA accepted Pharvaris's NDA for deucrictibant IR, an oral B2 antagonist for HAE attacks, based on phase 3 RAPIDe-3 data.

A look back at the FDA approvals, regulatory decisions, and pipeline updates in the pediatric health care space from June 2026.

A look back at the latest clinical trial updates for the pediatric population during June 2026.

FDA expands approval of roflumilast cream 0.3% for plaque psoriasis to children aged 2 years and older, offering the first topical PDE4 inhibitor.

A look back at the latest clinical trial updates for the pediatric population during the second quarter (April-June) of 2026.

FDA approved risankizumab for children 6 and older with plaque psoriasis or psoriatic arthritis, adding a weight-based 55-mg syringe for those under 40 kg.

A look back at the FDA approvals, label expansions, and regulatory decisions in the pediatric health care space from April through June 2026.

A preview of 5 pending FDA decisions for pediatric patients expected in the second half of 2026, spanning ADHD, psoriasis, a metabolic gene therapy, cardiomyopathy, and muscular dystrophy.

BM-3103 received FDA Fast Track designation for epidermolysis bullosa simplex as a phase 2 trial evaluates safety and efficacy.

Teva's NDA for ecopipam rests on phase 3 data showing a 50% relapse-risk cut, potentially the first new pediatric Tourette mechanism in a decade.

FDA approved the first generic rifapentine for active and latent tuberculosis, expanding treatment options for eligible pediatric patients.

In a parallel regulatory action, the European Medicines Agency has also validated a marketing application for Tivicay covering the neonatal indication.