News

The resubmission follows a prior Complete Response Letter (CRL) that identified chemistry, manufacturing, and control (CMC) issues.

FDA decisions, KDIGO guidelines, and federal nutrition updates redefine kidney care in January 2026

These new phase 2 INTEGUMENT-INFANT study findings point to the efficacy and safety of roflumilast cream 0.05% (Zoryve) in infants with eczema.

The CRL cited deficiencies limited to packaging and administration, with resubmission expected as early as Q3 2026.

Lee explains how understanding immune responses years before Crohn’s symptoms may open the door to earlier intervention and prevention strategies.

Freedman discusses a new analysis of the CARDIA study that indicates male patients’ greater risk of CHD at younger ages.

Although patients with remitted MDD showed greater impulsivity than controls, a study found no link between delay discounting and relapse risk after stopping antidepressants.

Stay updated with the latest healthcare breakthroughs, including new phase 2 obesity data, FDA actions, and new hematology guidelines in this week’s essential news roundup.

Lee explains what is known about the preclinical phase of Crohn’s disease before symptoms appear and describes his study on the role immune dysregulation plays.

The Maui Derm Hawaii 2026 conference featured a poster presentation highlighting recent phase 3 findings on risankizumab in pediatric patients.

In this segment, Nancy Reau, MD, and Kimberly Brown, MD, discuss ongoing challenges with viral hepatitis elimination efforts and clinical shortcomings in screening.

New data suggest asthma-related depression may be biologically distinct from MDD, with greater serum BDNF tied to worse disease severity and lower physical activity.

Since 1990, the prevalence of individuals with a BMI ≥30 has increased dramatically, and without significant intervention, will continue to do so.

Kianersi discusses how, although evening chronotype can be associated indirectly with increased CVD risk, this can be mediated via Life’s Essential 8 scores.

At the Maui Derm Hawaii 2026 conference, Lawrence Eichenfield, MD, spoke about highlights from his talk, ‘Atopic Dermatitis and Pruritus: Current Concepts and Therapeutics for 2026.’

The safety and efficacy of risankizumab versus deucravacitinib were evaluated among patients with moderate psoriasis and no prior biologic use.

The US Centers for Medicare & Medicaid Services selected 15 high-cost drugs for the third cycle of the Medicare Drug Price Negotiation Program, including the first-ever Part B drugs.

Milestone Pharmaceuticals’ novel, self-administered medication for paroxysmal supraventricular tachycardia has released alongside a patient support program.

Robert Negrin discusses ASH initiatives to sustain hematology research, early-career careers, and global clinical programs.

Nancy Reau, MD, and Kimberly Brown, MD, discuss the challenges of accurately assessing and addressing alcohol use in patients with MASLD.

With the acceptance, the FDA has assigned the oral phosphate binder a Prescription Drug User Fee Act target action date of June 29, 2026.

The FDA approval is based on a pair of phase 3 trials, including the larfest and longest safety study of presbyopia eye drops.

This Q&A interview with Dawn Eichenfield, MD, PhD, highlights notable takeaways from her session at Maui Derm Hawaii titled ‘Pediatric Dermatology 2026.’

This interview with Stein Gold continues her discussion of new and emerging psoriasis therapies in 2026.

ASH’s multidisciplinary panel provides a standardized diagnostic pathway emphasizing early laboratory testing and surrogate biopsies.

Noureddin recaps recent progress in MASH therapeutic development and looks ahead to what 2026 and beyond may offer.

This interview at the 2026 Maui Derm Hawaii meeting features a discussion of new and emerging therapies in psoriasis, including icotrokinra.

Reau and Brown discuss new data on MASH/MASLD, including awareness, referral patterns, discussions around alcohol, and emerging pharmacotherapies.