FDA Approves Bysanti, Next Generation Fanapt

On Feb. 20, 2026, the US Food and Drug Administration (FDA) approved Bysanti™ (milsaperidone – Vanda Pharmaceuticals) oral tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. Bysanti is a new chemical entity in the atypical antipsychotic class that rapidly interconverts to iloperidone (Fanapt), an antagonist of dopamine D2, serotonin 5‑HT2A, and alpha1‑adrenergic receptors. Approval was supported by data that demonstrated bioequivalence to iloperidone, marketed as Fanapt® by Vanda Pharmaceuticals. The recommended dose follows a twice-daily oral titration schedule to reduce the risk of orthostatic hypotension, beginning at 1mg twice daily and increasing as tolerated to a maximum of 12mg twice daily. Bysanti carries a boxed warning for increased mortality in elderly patients with dementia‑related psychosis and is not approved for use in this population. Serious warnings and precautions include QTc interval prolongation, neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, orthostatic hypotension and syncope, seizures, leukopenia and neutropenia, hyperprolactinemia, and risk of falls. Vanda anticipates commercial availability in the third quarter of 2026. Bysanti is also being evaluated as a once‑daily adjunctive therapy in treatment‑resistant major depressive disorder, with study completion expected later in 2026. Fanapt is scheduled to lose patent protection on Nov. 2, 2027. Here is the prescribing information.

FDA Converts Braftovi to Full Approval in Colorectal Cancer

The FDA granted traditional approval to Pfizer’s Braftovi^® (encorafenib) in combination with cetuximab and fluorouracil‑based chemotherapy for the treatment of adult patients who have metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation, as detected by an FDA‑authorized test. This decision converts the regimen’s December 2024 accelerated approval to full approval based on confirmatory efficacy data from the phase III BREAKWATER trial, in which it significantly improved median progression‑free survival (12.8 months vs. 7.1 months) and overall survival (30.3 months vs. 15.1 months) compared with standard chemotherapy with or without bevacizumab, with a significantly higher objective response rate (61% vs. 40%). For prescribing information, see here.

Leqvio Prescribing Information Updated with Pediatric Indications and Safety Revisions

On Feb. 12, 2026, the FDA approved labeling updates for Leqvio^® (inclisiran), Novartis’ small interfering RNA (siRNA) therapy targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), expanding its use to pediatric patients aged 12 years and older who have heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH). The updated label now indicates Leqvio is approved as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL‑C) in adults who have hypercholesterolemia, adults and pediatric patients 12 years and older who have HeFH, and pediatric patients 12 years and older who have HoFH. The recommended dosage for adults and pediatric patients 12 years and older is 284mg administered as a subcutaneous (SC) injection initially, again at three months, and then every six months. In addition to the indication expansion, the FDA required labeling changes based on post‑marketing experience, including the addition of hypersensitivity reactions to Contraindications and Warnings and Precautions, with corresponding updates to Postmarketing Experience and Patient Counseling Information. Updated prescribing information is available here.

BioMarin Withdraws Roctavian from the Market

On Feb. 23, 2026, BioMarin Pharmaceuticals announced that it will voluntarily remove Roctavian^® (valoctocogene roxaparvovec-rvox), a one-time intravenous (IV) gene therapy, from the market effective May 29, 2026, after it was unable to identify a qualified buyer following earlier plans to divest the product. The decision is not related to Roctavian’s safety or efficacy, and it will continue to support patients who have already received treatment through ongoing monitoring, patient support services, and existing outcomes-based payer agreements. Approved on June 29, 2024, Roctavian delivers a functional gene encoding for factor VIII for adults who have severe hemophilia A and do not have pre-existing antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test. Impacting mostly males, hemophilia A affects between 30,000 and 33,000 men in the US. Individuals who have hemophilia A are at risk for severe, life-threatening bleeding from common injuries and painful spontaneous bleeding into the joints and muscles. Patients who were considering Roctavian should discuss next steps with their health care providers, as treatment may shift to other FDA-approved treatments, such as non-factor prophylaxis therapies or factor VIII replacement prophylaxis, with on-demand bleed treatment as needed.

Dupixent Gets New Indication as First‑Ever Therapy for Allergic Fungal Rhinosinusitis

On Feb. 24, 2026, the FDA approved Dupixent® (dupilumab) for the treatment of adult and pediatric patients aged six years and older who have allergic fungal rhinosinusitis (AFRS) who have a history of sinonasal surgery, marking the first FDA‑approved drug specifically indicated for AFRS. Dupixent is a monoclonal antibody that inhibits interleukin (IL)‑4 and IL‑13 signaling through IL‑4 receptor alpha blockade, addressing the type two inflammatory pathway underlying AFRS, and is now approved for nine type two–driven diseases across the sino‑nasal, skin, gut, and respiratory systems.AFRS is an uncommon, chronic, and recurrent subtype of chronic rhinosinusitis caused by allergic hypersensitivity to fungi, most often affecting adolescents and young adults in warm, humid climates. Historically managed with surgery and prolonged systemic corticosteroids, AFRS can lead to sinus expansion, bone erosion, facial deformities, and vision or neurologic involvement, with recurrence common despite treatment. Approval was supported by results from a phase III randomized, placebo‑controlled trial, in which Dupixent significantly improved sinus opacification, nasal congestion, nasal polyp burden, and sense of smell, while reducing the need for systemic corticosteroids or additional surgery compared with placebo. It demonstrated a safety profile consistent with prior dupilumab experience, with overall findings showing that benefits outweighed risks in this population. The recommended dose is 300mg SC every two weeks. Here is the prescribing information.

Zepbound KwikPen Now Approved

On Feb. 23, 2026, Eli Lilly announced that Zepbound^® (tirzepatide), a once‑weekly dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1)  receptor agonist, is now available in a new four‑dose, single‑patient‑use KwikPen^® for chronic weight management in adults who have obesity or are overweight with at least one weight‑related comorbidity. The multi‑dose pen delivers a full month of therapy in one device. Updated prescribing information is here.

First Generic Atrovent HFA

On Feb. 24, 2026, the FDA approved Amphastar Pharmaceuticals’ ipratropium bromide HFA inhalation aerosol (17mcg per actuation) for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, in adult patients. Amphastar is eligible for 180 days of generic drug exclusivity, beginning upon commercial launch, which is expected early in the second quarter of 2026. Per IQVIA, US sales were approximately $112 million for 2025.

New Desmopressin Oral Solution for Central Diabetes Insipidus

The FDA approved Eton Pharmaceuticals’ Desmoda^™ (desmopressin acetate) oral solution (0.05mg/mL) for the management of central diabetes insipidus (arginine vasopressin deficiency) as antidiuretic replacement therapy in patients of all ages on Feb. 25, 2026. Central diabetes insipidus is a rare disorder caused by insufficient vasopressin production that leads to excessive urination and thirst, and is treated with desmopressin, which requires careful, individualized dosing to avoid complications from over‑ or under‑replacement. Eton estimates more than 13,000 people in the US have central diabetes insipidus, including up to 4,000 pediatric patients. This is the first FDA‑approved oral liquid formulation of desmopressin, offering an alternative to tablets that have required splitting or crushing to achieve precise dosing. The ready‑to‑use solution requires no refrigeration, mixing or shaking.  Launch is expected on March 9, 2026, with limited distribution through a specialty pharmacy. For prescribing information, see here.

FDA Grants First-Line Indication to Hernexeos for NSCLC                                                 

On Feb. 26, 2026, the FDA granted an expanded indication under accelerated approval to Boehringer Ingelheim’s Hernexeos® (zongertinib) tablets for the treatment of adults who have unresectable or metastatic, non‑squamous non‑small cell lung cancer (NSCLC) whose tumors harbor HER2 (ERBB2) tyrosine kinase domain–activating mutations, as detected by an FDA‑authorized test. The oral kinase inhibitor is now approved as an initial treatment option, expanding the prior August 2025 accelerated approval in previously treated patients. Approval was based on results from the single‑arm trial, in which 76% of treatment‑naïve patients (n=72) achieved an objective response, with 64% of responders maintaining benefit for at least six months. The recommended dose is weight‑based, with 120mg once daily for patients under 90kg and 180mg once daily for patients 90kg or more, taken with or without food. Label warnings include hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryo‑fetal toxicity, and continued approval is contingent on confirmation of clinical benefit in a post‑approval study that is currently enrolling patients with results expected in 2029. This is the second approval issued under the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program, with this review completed in 44 days. Prescribing information can be found here.

Recall

Urgent Correction Issued for TRUE METRIX Instructions On Feb. 6, 2026, Trividia Health initiated an Urgent Medical Device Correction for TRUE METRIX® Blood Glucose Monitoring Systems (including TRUE METRIX AIR®, TRUE METRIX GO®, and TRUE METRIX PRO®). The Center for Devices and Radiological Health (CDRH) at the FDA also issued an Early Alert to notify the public of a potential high-risk device issue. The correction was prompted by inadequately emphasized instructions regarding the E-5 error code, which can indicate very high blood glucose levels (>600mg/dL) or a test strip error and could potentially lead to delays in seeking medical care. Reported medically significant outcomes associated with this issue include 114 serious injuries and one death, attributed to the delayed treatment of severe hyperglycemia. The TRUE METRIX Blood Glucose Monitoring Systems are FDA‑cleared medical devices intended for the self-monitoring or professional monitoring of blood glucose levels in individuals with diabetes. The affected products include TRUE METRIX systems as well as multiple private‑label and co‑branded versions distributed through retail pharmacies, grocery chains, and other distributors. For updated instructions and to read more about the correction, see here.