FDA actions, week of October 5, 2026: 3 approvals, 5 rules, 7 notices, 1 announcement

Each line below links the stream brief and the agency's own record, grouped by the type of record.

Approvals

FDA approves tucatinib with trastuzumab and pertuzumab for HER2-positive breast cancer maintenance. On October 7, 2026, the FDA approved tucatinib (Tukysa, Seagen Inc., a subsidiary of Pfizer) in combination with trastuzumab and pertuzumab for adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment. The approval follows a randomized, double-blind, placebo-controlled trial of 654 patients that showed a median progression-free survival of 24.9 months versus 16.3 months in the placebo arm. Source: FDA approval page, October 7, 2026.
FDA approves atezolizumab with chemotherapy for Stage III dMMR colon cancer. On October 8, 2026, the FDA approved atezolizumab (Tecentriq, Genentech, Inc.) with fluoropyrimidine and oxaliplatin for adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient colon cancer. The approval also covers atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for patients 12 years and older who weigh 40 kg or greater. Source: FDA approval page, October 8, 2026.
FDA approves Hovilpri for immunocompromised patients with HSV lesions. The FDA approved Hovilpri (pritelivir) tablets for adults with weakened immune systems who have mucocutaneous lesions caused by herpes simplex virus and have not responded to acyclovir, valacyclovir, or famciclovir. In a Phase 3 trial, 63% of patients treated with Hovilpri had all lesions healed by 28 days versus 34% with other medications. Source: FDA approval page, October 9, 2026.

Final rules

FDA finalizes exemption for certain class II clinical toxicology test systems. The FDA issued a final order exempting specific class II clinical toxicology test systems from premarket notification (510(k)) requirements, effective October 6, 2026. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. Source: Federal Register rule, October 6, 2026.
FDA finalizes class II status for hyperoxia monitoring device adjunct to pulse oximetry. The FDA issued a final order on October 6, 2026, classifying the hyperoxia monitoring device adjunct to pulse oximetry into class II with special controls. The order, effective October 6, 2026, codifies the classification that was first applied on October 12, 2023. Source: Federal Register rule, October 6, 2026.
FDA classifies focused ultrasound system as class II. The Food and Drug Administration issued a final order classifying the focused ultrasound system for non-thermal, mechanical tissue ablation into class II with special controls, effective October 6, 2026. The order codifies the classification in 21 CFR 878.4405 and identifies the special controls that will provide reasonable assurance of safety and effectiveness. Source: Federal Register rule, October 6, 2026.
FDA classifies infant pulse rate and oxygen saturation monitor as class II. The order assigns the device to class II, adding special controls to the codified language. The action is expected to enhance patients' access to beneficial innovative devices by reducing regulatory burdens. Source: Federal Register rule, October 9, 2026.
FDA classifies hematopoietic cell enrichment kit as class II device. The order designates the kit as a class II device with special controls. The special controls will be part of the codified language for classification of the hematopoietic cell enrichment kit. Source: Federal Register rule, October 9, 2026.

Notices

FDA determines pralidoxime chloride AUTOINJECTOR not withdrawn for safety or effectiveness. FDA has determined that pralidoxime chloride AUTOINJECTOR solution, 600 mg/2 mL (300 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications for the product if other requirements are met. Source: Federal Register notice, October 6, 2026.
FDA issues priority review voucher for FAYUVI (rebisufligene etisparvovec-hopf). The FDA announced that it has awarded a priority review voucher to the sponsor of FAYUVI, a gene therapy approved on September 17, 2026. The voucher is granted to Ultragenyx Pharmaceutical Inc. for this rare pediatric disease product that meets the criteria under the FD&C Act. Source: Federal Register notice, October 6, 2026.
FDA requests public comments on ibogaine trial design. FDA is opening a docket to receive comments on design elements for early-phase trials of ibogaine drug products, with a deadline of November 20, 2026. The request follows guidance issued July 14, 2026 and seeks input on dose selection, safety monitoring, eligibility criteria and other protocol elements. Source: Federal Register notice, October 6, 2026.
FDA issues priority review voucher for ZANVASTRO. FDA approved ZANVASTRO on September 3, 2026. FDA issued a priority review voucher to the sponsor, Ionis Pharmaceuticals, Inc., after determining the product meets the criteria under the FD&C Act. Source: Federal Register notice, October 9, 2026.
FDA withdraws approval of 37 ANDAs. The agency is withdrawing approval of 37 abbreviated new drug applications from multiple applicants. The applicants notified the FDA that the drug products were no longer marketed and requested the approvals be withdrawn. Source: Federal Register notice, October 9, 2026.
FDA withdraws approval of Amneal's celecoxib ANDA. FDA withdraws approval of abbreviated new drug application 208833 for celecoxib capsules 50 mg, 100 mg, 200 mg, and 400 mg held by Amneal Pharmaceuticals of New York, LLC. Amneal requested the withdrawal and waived its opportunity for a hearing. Source: Federal Register notice, October 9, 2026.
FDA corrects withdrawal notice of 16 ANDAs. The FDA issued a correction to a June 3, 2026 notice that announced the withdrawal of approval of 16 abbreviated new drug applications, effective July 6, 2026. The correction removes entries for ANDA 207366, ANDA 212957, and ANDA 218638, noting that Navinta LLC requested the approvals not be withdrawn, so those approvals remain in effect. Source: Federal Register notice, October 9, 2026.

Other announcements

FDA seeks public input to support ibogaine research. The FDA issued a request for information (RFI) to gather comments on early-phase clinical trial design for ibogaine drug products, including dose selection, safety monitoring and ethical oversight. Stakeholders have 45 days to submit comments, with the deadline on Friday, November 20, 2026. Source: FDA press announcement, October 5, 2026.

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