Drug Watch

The accelerated FDA approval, based on Replimune's phase 2 IGNYTE trial data, gives clinicians a new second-line option for adults with advanced melanoma progressing after anti-PD-1 therapy.

Aaron Farberg, MD, discusses how localized isotretinoin delivery may affect treatment burden, tolerability, and adherence.

Absci's ABS-201 posts early phase 1 safety and long half-life, while new data show prolactin-receptor blockade may revive hair growth in AGA.

The European Commission greenlights upadacitinib for severe alopecia areata, with phase 3 data showing rapid scalp, brow and lash regrowth; US decision still pending.

Faculty at Elevate-Derm Summer 2026 discussed the expanding role of oral JAK inhibitors in pediatric dermatology, emphasizing earlier intervention, individualized patient selection, safety monitoring, and family-centered counseling.

Two phase 3 trials of Pfizer's ritlecitinib met co-primary end points for facial and total repigmentation in nonsegmental vitiligo at week 52, prompting plans for global regulatory filings.

Aaron Farberg, MD, discusses how Isoclear aims to deliver isotretinoin directly to the skin through a customizable compounded topical system while avoiding the monitoring requirements associated with oral therapy.

July's FDA news was quiet, but an infant AD filing, JAK-refractory alopecia data, and a new device clearance hint at what's next.

Phase 1 results show Bambusa Therapeutics’ BBT001 quickly reduces atopic dermatitis and itch, sustains type 2 biomarker suppression, and may enable quarterly dosing.

Sanofi will not submit the OX40-ligand antibody for regulatory review, citing efficacy and safety data insufficient to improve upon current standard-of-care treatments for moderate to severe AD.

New phase 3 data presented at the AAD Innovation Academy show zasocitinib achieved high rates of clear or almost clear skin at the scalp, palms, soles, and nails at week 16.

New phase 3 data show oral TYK2 inhibitor soficitinib improves moderate-to-severe atopic dermatitis, easing itch with no new safety signals.

Extended-release oral minoxidil candidate VDPHL01 improved hair counts and patient-reported outcomes in women with pattern hair loss in a phase 2 study.

Q32 Bio reported bempikibart reduced SALT scores by 35.3% and produced a SALT-20 response in 40.0% of patients at week 36 in the SIGNAL-AA phase 2a trial.

TRAPEDS-1 met its primary pharmacokinetic objective in children aged 6 to 11 years with moderate to severe atopic dermatitis, with no new safety signals over up to 172 weeks of tralokinumab treatment.

Forte Biosciences' FB102 shows significant facial repigmentation in a phase 1b vitiligo trial, with gains continuing 12 weeks post-treatment and mild adverse effects.

Lynk Pharmaceuticals has dosed the first patient in a phase 2 trial evaluating investigational topical pan-JAK inhibitor LNK01004 for vitiligo.

The FDA accepted Arcutis' supplemental NDA seeking to expand roflumilast cream 0.05% to infants aged 3 months to younger than 2 years with mild to moderate AD.

Teva Pharmaceuticals will advance TEV-'408 into phase 2b after encouraging phase 1b vitiligo data showed repigmentation, favorable safety, and quarterly dosing potential.

Turn Therapeutics finalized its stage 2 trial design after interim data showed clinically meaningful GX-03 efficacy in patients with baseline EASI scores as low as 1.1.

Can-Fite completed interim enrollment for its pivotal phase 3 trial of first-in-class oral A3AR agonist piclidenoson, a potential new mechanism for plaque psoriasis.

AbbVie's upadacitinib received a positive CHMP opinion for severe alopecia areata as FDA review continues in the US.

The approval expands the existing indication for adults and children down to age 6, includes intertriginous areas, and removes restrictions on duration of use.

Evommune's EVO756 failed to meet the primary end point in a phase 2b trial for chronic spontaneous urticaria, prompting the company to discontinue development for the indication while continuing studies in atopic dermatitis.

The FDA has accepted Replimune's third resubmitted BLA for RP1 plus nivolumab in advanced melanoma, setting an August 2 PDUFA date.