FDA News Recap: Novel Drug Approvals in First Half of 2025

Remibrutinib doubled complete Total Fric Score response vs placebo at week 12 in RemIND, becoming the first therapy approved specifically for SD.

Ryaltris pediatric approval, lonvo-z and deucrictibant HAE filings, PVX108 Fast Track, and Palforzia's exit headline Q3 2026 allergy news.

Lasker Award winners Takehisa Kitazawa and Tomoyuki Igawa discuss prophylaxis gains, remaining unmet needs, and lessons for drug discovery.

In the phase 3 RAPIDe-3 trial published in The Lancet, median time to symptom relief was 1.28 hours with deucrictibant vs more than 12 hours with placebo.

Lasker Award winners Kunihiro Hattori, Takehisa Kitazawa, and Tomoyuki Igawa recount the 2400 variants behind the drug.

Weltruza requires no loading doses, oral supplementation, or post-injection monitoring, with approval based on the phase 3 SOLARIS trial.

With the Viaskin Peanut BLA filed for ages 4 to 7, here's where the patch, omalizumab, and office OIT fit for peanut allergy.With the Viaskin Peanut BLA filed for ages 4 to 7, here's where the patch, omalizumab, and office OIT fit for peanut allergy.

The guideline chair answers key questions on new ferritin cutoffs, symptoms without anemia, inflammation, and lab reporting.