FDA Updates

The indication is for patients who have received 1 to 3 prior systemic treatment regimens, of which at least 1 includes bevacizumab.

FDA approves nivolumab with AVD for stage III/IV classical Hodgkin lymphoma, boosting PFS and redefining first-line care.

The expanded indication is supported by findings from the phase 3 TRANSCEND clinical trial.

FDA fast-tracks higher-dose weekly semaglutide, showing up to 20.7% weight loss.

FDA approval of linerixibat brings the first targeted oral relief for cholestatic pruritus in primary biliary cholangitis, easing relentless autoimmune itch fast.

Icotrokinra, a first-in-class oral IL-23 receptor blocker, fills a long-standing gap in the treatment of moderate to severe plaque psoriasis.

New once-daily oral peptide blocks IL‑23 receptor, delivering high skin clearance and strong safety for moderate-to-severe plaque psoriasis in ages 12+.

Novo Nordisk's Nicky Kelepouris, MD, discusses the REAL8 trial, the expanded pediatric indications for once-weekly somapacitan, and the pharmacist's role in supporting families navigating long-term growth hormone therapy.

FDA approves secukinumab for adolescents 12 years and older with moderate to severe hidradenitis suppurativa, offering the first IL-17A option and new hope for earlier relief.

The approval is significant for a condition that is estimated to affect fewer than 1 in 1 million individuals.

Ipsen discontinues tazemetostat after SYMPHONY-1 safety signals; pharmacists and FDA guide next steps for EZH2-mutant follicular lymphoma patients.

The FDA approves Bristol Myers Squibb’s deucravacitinib (Sotyktu), a first oral tyrosine kinase 2 inhibitor for active psoriatic arthritis.

FDA approval expands the use of teclistamab plus daratumumab, which significantly improved survival in the MajesTEC-3 trial.

Lomitapide demonstrated substantial LDL cholesterol reductions in a pivotal trial.

Milsaperidone is indicated for acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of schizophrenia in adults.

FDA priority review of rusfertide signals a new PV option, cutting phlebotomy reliance and improving hematocrit control, with pharmacists guiding injections and safety.

Somapacitan-beco becomes the first and only once-weekly growth hormone approved for children with idiopathic short stature, those born small for gestational age, and those with Noonan syndrome, offering an alternative to daily injections.

The approval is supported by findings from the phase 1 Beamion LUNG-1 clinical trial.

The oral solution improves central diabetes insipidus dosing precision, helping pharmacy teams tailor therapy, counsel patients, and monitor hyponatremia.

The approval for the oral, fixed-duration chronic lymphocytic leukemia (CLL) regimen was based on results from the phase 3 AMPLIFY trial.

FDA approves encorafenib plus cetuximab chemotherapy for BRAF V600E metastatic colorectal cancer, boosting survival and response in BREAKWATER.

FDA clears pegzilarginase-nbln enzyme therapy for ARG1-D, cutting toxic arginine and boosting mobility.

With this action, dupilumab has become the first and only FDA-approved treatment for allergic fungal rhinosinusitis.

The FDA accepts Moderna’s mRNA flu vaccine filing, targeting adults 50 years and older, with an accelerated path for older adults and a 2026 decision deadline.

FDA accepts Iberdomide new drug application for relapsed or refractory multiple myeloma; pharmacists prepare for oral anti-CD38 combos, MRD-driven care.

FDA approves difamilast (Adquey), a topical PDE4 inhibitor, expanding nonsteroidal options for mild to moderate atopic dermatitis in dermatology patients 2 years and older.

The FDA approves a once-monthly dosing schedule for amivantamab and hyaluronidase-lpuj to optimize administration and cut down infusion times.

The biosimilar is a cost-effective treatment for patients with conditions caused by cancer treatment.