FDA Expands Simponi Approval to Pediatric Ulcerative Colitis

On Oct. 7, 2025, the US Food and Drug Administration (FDA) approved Johnson & Johnson Innovative Medicine’s Simponi^® (golimumab) for the treatment of moderate to severe active ulcerative colitis (UC) in pediatric patients who weigh at least 15kg. Previously approved for adult UC, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, Simponi is now approved for children with UC every four weeks. Of the estimated one million Americans who have UC, about 200,000 are pediatric patients. Approval of the human monoclonal antibody that targets and neutralizes tumor necrosis factor alpha (TNF-α), was based on phase III data showing 32% of patients achieved clinical remission at week six, 58% showed clinical response and 40% demonstrated endoscopic improvement. The recommended dose varies by weight. For patients weighing at least 40kg, the recommended dose is 200mg at week zero, followed by 100mg at weeks two and six, and then every four weeks thereafter. For those weighing between 15kg and 40kg, the recommended dose is 100mg at week zero, followed by 50mg at week two and, and then every four weeks thereafter.. Simponi is administered subcutaneously (SC) via pre-filled syringe and may be self-administered by patients aged 12 years and older after proper training. Here is the updated prescribing information.

Rinvoq’s Ulcerative Colitis and Crohn’s Disease Indications Updated

The FDA updated the labeling for Rinvoq^® (upadacitinib – AbbVie) on Oct. 13, 2025. It is now approved for use in adults with moderately to severely active UC or Crohn’s disease who have received at least one approved systemic therapy, when TNF blockers are clinically inadvisable. Previously, the oral Janus kinase (JAK) inhibitor was only indicated for adults who have had an inadequate response or intolerance to one or more TNF blockers. It is estimated that about 400,000 Americans with moderate to severe disease may be unsuitable for TNF blockers due to comorbidities. Rinvoq carries a boxed warning outlining the increased risk of blood clots, cancer, cardiovascular events and serious infections that may be associated with the use of any JAK inhibitor, including Rinvoq. Patients taking one of the drugs in the class also should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. Look here for Rinvoq’s current prescribing information.

Uzedy Indication Expanded to Include Bipolar I Disease

On Oct. 10, 2025, the FDA expanded Teva Pharmaceuticals’ Uzedy^® (risperidone) extended-release injectable suspension approval to include treatment as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder (BD-I) in adults. Uzedy is a long-acting injectable (LAI) atypical antipsychotic previously approved for schizophrenia, and utilizes SteadyTeq^™ technology, a delivery system enabling subcutaneous administration every one or two months. The recommended dose for BD-I depends on prior risperidone exposure as patients stabilized on oral risperidone should initiate Uzedy at a clinically appropriate dose, while those switching from a biweekly long-acting intramuscular risperidone injection should begin Uzedy at least five weeks after the last injection, using a conversion table listed in the package insert. Injections are given SC monthly by a healthcare provider. Uzedy carries a boxed warning concerning increased mortality in elderly patients who have dementia-related psychosis. Risperdal Consta^® (risperidone – Johnson and Johnson Innovative Medicine, generics) is another LAI atypical antipsychotic. It is administered as an intramuscular (IM) injection every two weeks. Here is the updated prescribing information for Uzedy.

New Dasatinib Formulation Launch Eases Coadministration with Acid-Reducing Agents

Cycle Pharmaceuticals announced the launch of Phyrago^™ (dasatinib) tablets on Oct. 16, 2025. Previously approved in 2023, Phyrago is indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in adults and pediatric patients at least one year of age, as well as Ph+ acute lymphoblastic leukemia (ALL) in both newly diagnosed and treatment-resistant populations. The formulation is bioequivalent, but not generic, to Sprycel^® (dasatinib – Bristol Myers Squibb), both tyrosine kinase inhibitors (TKI). The Phyrago formulation allows for concomitant use with proton pump inhibitors (PPIs) and H₂ receptor antagonists (H₂RAs). Sprycel requires an acidic environment for absorption and therefore PPIs and H₂RAs can reduce absorption and efficacy. Here is the prescribing information.

MedWatch Update

FDA Adds Boxed Warning to Carvykti for Rare but Serious Intestinal Disorder On Oct. 10, 2025, the FDA approved labeling updates for Johnson & Johnson Innovative Medicine’s Carvykti^® (ciltacabtagene autoleucel), a B-cell maturation antigen (BCMA)-directed autologous chimeric antigen receptor T-cell (CAR-T) drug cell therapy, to include a boxed warning for immune effector cell-associated enterocolitis (IEC-EC). The condition, a rare but potentially fatal inflammation of the intestines triggered by the immune system, has been reported in clinical trials and post marketing surveillance, typically appearing weeks to months after infusion. Symptoms may include severe diarrhea, abdominal pain and weight loss, with some cases requiring total parenteral nutrition and immunosuppressive treatment. Fatal outcomes have been linked to intestinal perforation and sepsis. The recommended management for IEC-EC includes specialist referral and, in refractory cases, evaluation for T-cell lymphoma of the gastrointestinal tract. The updated label also includes overall survival (OS) data from the CARTITUDE-4 trial, which demonstrated a statistically significant OS benefit in patients with relapsed and lenalidomide-refractory multiple myeloma. Despite the new warning, the FDA said the overall benefits of Carvykti continue to outweigh the risks for patients with relapsed or refractory multiple myeloma. Here is the safety communication.