FDA Expands Bizengri Label to NRG1 Fusion‑Positive Cholangiocarcinoma

On May 8, 2026, the US Food and Drug Administration (FDA) approved a new indication for Partner Therapeutics’ Bizengri^® (zenocutuzumab‑zbco) for adults who have advanced, unresectable, or metastatic cholangiocarcinoma harboring a neuregulin-1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This approval marks the first FDA‑approved therapy for this subset of bile duct cancer, a rare, aggressive malignancy with poor prognosis and few effective later‑line options. First approved in 2024 for NRG1 fusion‑positive non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma, Bizengri is a human epidermal growth factor receptor (HER)2 and HER3-directed bispecific antibody designed to target NRG1‑driven signaling. Approval was supported by data demonstrating an objective response rate of 36.8% among evaluable patients (n = 19), with response durations ranging from 2.8 to 12.9 months. The most common adverse reactions include diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions (IRR), dyspnea, rash, constipation, vomiting, abdominal pain, and edema. The prescribing information includes warnings and precautions for infusion-related reactions, hypersensitivity and anaphylaxis, interstitial lung disease (ILD)/pneumonitis, left ventricular dysfunction, and a boxed warning for embryo-fetal toxicity. The recommended dose of Bizengri is 750mg every two weeks by intravenous (IV) infusion until disease progression or unacceptable toxicity. Premedication before each infusion is required to reduce the risk of reactions. The approval was expedited under the FDA’s Commissioner’s National Priority Voucher pilot program, the seventh drug cleared through the pathway, with the voucher awarded two days before approval. Here is the updated prescribing information.

Vyvgart Becomes First FDA‑Approved Therapy Covering All Adult gMG Serotypes

The FDA expanded argenx SE’s Vyvgart^® (efgartigimod alfa‑fcab) IV formulation and Vyvgart Hytrulo^® (efgartigimod alfa and hyaluronidase‑qvfc) subcutaneous (SC) formulation on May 8, 2026, and granted approval for the treatment of all adult patients who have generalized myasthenia gravis (gMG), regardless of antibody serotype, including anti‑acetylcholine receptor (AChR) antibodies, anti‑muscle‑specific kinase (MuSK) antibodies, anti‑lipoprotein receptor–related protein 4 (LRP4) antibodies, as well as patients who are triple seronegative. The approval expands the prior AChR‑positive-only indication and is the first FDA-approved therapy covering all adult gMG serotypes.  Approval was supported by rapid, statistically significant, and clinically meaningful improvements in Myasthenia Gravis Activities of Daily Living (MG‑ADL) scores versus placebo at week four, with sustained symptom control across functional domains including speech, vision, swallowing, and mobility. No new safety signals were observed. Updated prescribing information is available here.

FDA Safety Alert Reinforces Withdrawal of Tazverik Following Emerging Trial Data

On May 8, 2026, the FDA issued a safety alert to health care providers and patients regarding an increased risk of secondary hematologic malignancies associated with prior exposure to Tazverik^® (tazemetostat), reinforcing the rationale for Ipsen’s March 2026 voluntary market withdrawal. Tazverik is an oral EZH2 methyltransferase inhibitor that received accelerated FDA approval in 2020 for metastatic or locally advanced epithelioid sarcoma and for relapsed or refractory follicular lymphoma. The recent FDA alert was based on emerging safety findings from the ongoing SYMPHONY‑1 confirmatory trial, in which 5.7% of patients (18/318) treated with Tazverik developed treatment‑emergent secondary blood cancers, including myelodysplastic syndrome and acute leukemias, compared with none reported in the control arm. Events were observed as early as 7.5 months after treatment initiation and were considered serious and non‑reversible in most affected patients. Based on emerging safety signals, the FDA concluded that the benefit–risk profile no longer supports use of Tazverik. Enrollment in the SYMPHONY‑1 trial was halted, treatment with Tazverik was discontinued with patients transitioning to alternative therapies, and all ongoing studies and expanded access programs were stopped, with remaining participants followed for long‑term safety. Tazverik is no longer commercially available following Ipsen’s voluntary market withdrawal on March 9, 2026.

New Combination Approved as First All-Oral Treatment for Older, Unfit AML Patients

The FDA approved Taiho Oncology’s combination of Inqovi^® (decitabine and cedazuridine tablets) plus Venclexta^® (venetoclax) for the treatment of adult patients who have newly diagnosed acute myeloid leukemia (AML) who are aged 75 years and older or those who have comorbidities that preclude intensive induction chemotherapy on May 13, 2026. This combination is an all‑oral regimen and eliminates the need for parenteral administration, enabling outpatient administration. Approval was supported by data showing that the combination achieved a 41.6% complete response (CR) rate with a median time to CR of two months. The recommended regimen includes one Inqovi tablet containing decitabine 35mg and cedazuridine 100mg orally once daily on days one through five of each 28‑day cycle. It is to be given with Venclexta according to the ramp-up schedule, followed by 400mg daily dosing until disease progression or unacceptable toxicity. Prescribing information includes warnings and precautions related to myelosuppression and embryo‑fetal toxicity. Updated prescribing information is available here.

FDA Approves Fasenra for Hypereosinophilic Syndrome

On May 14, 2026, the FDA approved Fasenra^® (benralizumab – AstraZeneca) for the treatment of adult and pediatric patients aged 12 years and older who have hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. HES is a rare and potentially life-threatening disorder characterized by persistent levels of eosinophils and progressive organ damage, with limited targeted treatment options. Approval was based on the Phase III NATRON trial, in which benralizumab significantly prolonged time to first HES flare and reduced the risk of an initial flare by 65% compared with placebo, with consistent improvements in flare frequency and patient-reported fatigue outcomes. The recommended dose is 30mg administered subcutaneously once every four weeks. Common adverse reactions include headache, hypersensitivity reactions, and influenza-like illness. Serious warnings include the potential for hypersensitivity reactions, the need to avoid abrupt discontinuation of corticosteroids, and the risk for parasitic infections. Here is the prescribing information.

Recall

Dexcom Phasing Out G6 System

Dexcom, Inc. announced the planned discontinuation of the Dexcom G6 Continuous Glucose Monitoring (CGM) System effective July 1, 2026.  The discontinuation is part of a strategic transition to a new continuous glucose monitor (CGM), the Dexcom G7 and Dexcom G7 15 Day systems, and is not related to a safety or quality issue. Production of Dexcom G6 systems and related components will cease by the end of June 2026, and availability cannot be guaranteed beginning July 1, 2026. However, existing inventory may remain available through the end of 2026. Dexcom will continue to honor prescription refills while supply lasts and provide technical support for in-warranty devices. The Dexcom G6 CGM System is FDA approved for CGM in patients aged two years and older with diabetes, including those with type 1, type 2, or gestational diabetes.

Emerging Genetic Hearing Loss Treatment Landscape Issues Document Now Available

Genetic hearing loss treatments are rapidly shifting from supportive devices toward disease-modifying, gene-targeted therapies, creating new clinical, operational, and access considerations. This document was developed to educate stakeholders on OTOF-mediated hearing loss and to summarize Otarmeni’s FDA accelerated approval as the first approved gene therapy for hearing loss. It also provides a concise view of the OTOF gene therapy pipeline and emerging targets to help track how evidence, access models, and follow-up expectations are evolving.