The HCPFive: Top News for Healthcare Providers from the Week of 02/01

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration (FDA) issuance of a Complete Response Letter (CRL) o Aquestive Therapeutics’ New Drug Application (NDA) for dibutepinephrine (Anaphylm) Sublingual Film for the treatment of Type I allergic reactions, new phase 2 topline data from Arcutis Biotherapeutics for roflumilast (Zoryve) cream 0.05% in infants with atopic dermatitis, an accepted Biologics License Application from Galderma for RelabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines and lateral canthal lines, regulatory submissions for upadacitinib (Rinvoq; 15 mg, once daily) for the treatment of adult and adolescent patients living with non-segmental vitiligo, and topline results from the phase 2b VESPER-3 study of Pfizer’s PF’3944 (MET-097i) in adults with obesity or overweight without type 2 diabetes.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of February 01, 2026—let’s jump in!

FDA Issues CRL to Dibutepinephrine (Anaphylm) Sublingual Film for Type 1 Allergic Reactions

Announced on February 2, 2026, the FDA issued a CRL to Aquestive Therapeutics’ NDA for dibutepinephrine (Anaphylm) Sublingual Film for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing ≥ 30kg (approximately 66 pounds). The January 30, 2026, CRL detailed deficiencies in the dibutepinephrine human factors (HF) validation study, including instances of difficulty opening the pouch and incorrect film placement which, if unaddressed, the FDA believes could cause significant safety issues in the setting of anaphylaxis.

Positive Topline Data Released on Roflumilast Cream in Infants with Atopic Dermatitis

On February 2, 2026, Arcutis Biotherapeutics announced positive topline results from the INTEGUMENT-INFANT phase 2 study evaluating the safety, tolerability, and efficacy of roflumilast (Zoryve) cream 0.05% in infants aged 3 months to < 24 months with atopic dermatitis. In the study, the highly selective and potent topical PDE4 inhibitor was well tolerated with a safety profile consistent with previous clinical trials. Results showed roflumilast cream improved the severity of disease and reduced the area of skin affected by atopic dermatitis, with 58% of participants achieving EASI-75 at week 4.

FDA Accepts Resubmitted BLA for RelabotulinumtoxinA for Glabellar and Lateral Canthal Lines

On February 2, 2026, Galderma announced the FDA’s acceptance of the Company’s BLA resubmission for RelabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults. The acceptance follows collaboration between Galderma and the Agency to implement adjustments to the Company’s manufacturing process.

Upadacitinib Regulatory Applications Submitted for Adults, Adolescents with Vitiligo

On February 3, 2026, AbbVie announced the submission of applications to the FDA and EMA for a new indication for upadacitinib (Rinvoq; 15 mg, once daily) for the treatment of adult and adolescent patients living with non-segmental vitiligo (NSV). The regulatory submissions are supported by previously announced results from the Viti-Up studies evaluating the safety and efficacy of upadacitinib in patients with NSV.

VESPER-3: Positive Results of Long-Term GLP-1 PF’3944 in Overweight and Obesity Without T2D

On February 3, 2026, Pfizer announced positive topline results from the phase 2b VESPER-3 study investigating monthly maintenance dosing of its fully-biased, ultra-long-acting, injectable GLP-1 receptor agonist PF’3944 (MET-097i) in adults with obesity or overweight without type 2 diabetes. The study met the primary endpoint of statistically significant weight reduction at 28 weeks with a competitive tolerability profile. Of note, weight loss continued after the pre-planned switch from weekly to monthly dosing, with no plateau observed at 28 weeks.