FDA Updates

The interchangeable designation allows pharmacists to substitute Langlara for Lantus at the point of dispensing without prescriber intervention, a distinction that carries significant clinical and operational implications for pharmacy practice.

The agency's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List signals that large-scale compounding of these agents has no regulatory future, and carries immediate implications for pharmacy practice.

The approval follows positive results from a phase 3 randomized withdrawal trial.

The FDA expands teplizumab-mzwv use to ages 1+ with stage 2 type 1 diabetes, detailing PETITE-T1D safety, EBV/CMV precautions, and pharmacist support to delay onset.

The once-weekly Saphnelo Pen offers adult patients with systemic lupus erythematosus a new, at-home alternative to monthly intravenous infusions, supported by robust phase 3 data.

The actions will support the development of psychedelic-based therapies for PTSD, depressive disorders, and substance use disorders.

The treatment's approval was supported by positive evidence from the phase 1/2 CHORD clinical trial.

Dupilumab becomes the first biologic approved for children aged 2 to 11 years with uncontrolled chronic spontaneous urticaria, marking a significant expansion in treatment options and pharmacist-led care considerations.

FDA approval expands teplizumab-mzwv to patients 1 year and older, helping delay type 1 diabetes onset for children with stage 2 diabetes.

This decision builds upon the drug’s initial approval for adult patients and introduces a new therapeutic option for clinicians treating pediatric populations with rapid heart rate disturbances.

The indication is to reduce proteinuria in adults and children aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic symptoms.

This is the second complete response letter the manufacturer has received for this treatment regimen.

Waters Corporation's Onclarity HPV Self-Collection Kit represents a significant advance in expanding access to cervical cancer screening outside the clinic.

The approval is supported by clinical data from the ATTAIN-1 and ATTAIN-2 trials.

The updated dosing schedule for nusinersen offers increased drug exposure and may further improve outcomes for patients with spinal muscular atrophy.

The FDA removed the age requirement from the neffy 1-mg label, allowing use based solely on weight and expanding access to younger pediatric patients at risk for anaphylaxis.

The safety and effectiveness of marne-cel were established in an open-label, single-arm, multicenter phase 1/2 clinical trial.

Insulin icodec-abae injection becomes the first and only once-weekly basal insulin option, offering personalized care for adults with type 2 diabetes (T2D).

The approval is a milestone for rare disease that has lacked treatments capable of crossing the blood-brain barrier and introduces a new class of agent that pharmacists will need to understand.

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.