Drug Watch

The FDA has set a PDUFA target action date of May 22, 2025.

Bimzelx was also approved for non-radiographic axial spondyloarthritis and ankylosing spondylitis.

Ebglyss is now approved for children and adults aged 12 years and older.

The rates of discontinuation due to inefficacy or adverse events for biosimilars and originators of etanercept and adalimumab were similar, according to an analysis of a prospective registry.

The PD-1/IL-2α bispecific antibody fusion protein is intended for patients with unresectable locally advanced or metastatic melanoma.

The overall reduction of tumor size in all lesions treated in part 2 was approximately 86%.

Galderma’s nemolizumab is the first approved monoclonal antibody specifically inhibiting the signaling of IL-31.

The approval is supported by positive phase 3 data for Lymphir in this indication.

Alumis' Martin Babler shared insights into the program for the TYK2 inhibitor and the company's next steps for its development.

This article represents the first time the news has been shared with the public. Turn's Founder and CEO, Bradley Burnam, shares details.

Take a deep dive into the 3 approvals for various dermatological conditions this month.

Approved down to the age of 6, the treatment is covered by 2 pharmacy benefit manager contracts to provide timely coverage.

Iltefat Hamzavi, MD, discusses the REGINA 007 phase 2 trial evaluating MK-6194 for the treatment of non-segmental vitiligo.

Along with the approval, Sun Pharma is introducing an access program to assist eligible patients in starting and adhering to the treatment.

The submission to the FDA is supported by positive results from the ARRECTOR phase 3 trial.

Patrick Burnett, MD, PhD, provides insights into the significance of Arcutis’ roflumilast cream 0.15% formulation and its impact on pediatric patients.

The planned PDUFA data was July 7, 2024.

Iain Stuart, PhD, discusses VYN202's status and potential in psoriasis and immuno-inflammatory diseases.

Pyzchiva will be commercialized by Sandoz in the United States.

Ensemble No.2, or ENS-002, is an investigational live biotherapeutic product first detected by Concerto Biosciences using its kChip technology.

Authorization for Eli Lilly's Ebglyss is based on positive results from the ADvocate 1, ADvocate 2, and ADhere studies.

Botanix Pharmaceuticals announced the approval of its sofpironium topical gel, 12.45% for adults and children ages 9 and older.

Stefan Weiss, MD, MBA, explains next steps for the oral treatment after the completion of phase 1b enrollment.

LEO Pharma's Adbry, a single-dose autoinjector, is expected to become available to patients in the coming months.

Roflumilast cream 0.15% is being evaluated for patients with mild to moderate atopic dermatitis down to 6 years.

Researchers found dupilumab improved itch and skin lesions regardless of atopic disease status in patients with PN.

The primary efficacy endpoint is the proportion of subjects achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index.

Phase 3 trials have been initiated in patients with high-risk melanoma.

The phase 2 study achieved the primary end point of a >30% Severity of Alopecia Tool score improvement.

The month of May has been full of pipeline news, including updates on VYN201 for nonsegmental vitiligo, imsidolimab for GPP, sonelokimab for HS, and more.