FDA approvals: Hovilpri, Jaypirca and the Juveena hydrogel lead the Oct. 2–9 ledger
A date-bounded ledger of the FDA's October 2–9, 2026 decisions, led by the first drug approved for resistant herpes simplex lesions, a first-line CLL approval for pirtobrutinib, and the two original device approvals the agency's own feeds had only just begun to carry.
The FDA's week closed on October 9 with Hovilpri (pritelivir), the year's forty-sixth novel drug and the first therapy the agency has approved for herpes simplex virus lesions that have stopped responding to acyclovir, valacyclovir and famciclovir in adults with weakened immune systems. 12
Four label expansions fill the days before it — Jaypirca into previously untreated chronic lymphocytic leukemia, Tecentriq into adjuvant colon cancer, Tukysa into breast-cancer maintenance, and Rhapsido into a second form of chronic hives — alongside Teva's first once-monthly subcutaneous olanzapine injection. 34567
Device records reached public surfaces late in the week, and two matter. The PMA database now carries the pediatric heart valve approved on October 1, and the same feed added a second original approval dated September 28 for a uterine hydrogel. 89
Three capture boundaries set how complete this ledger is, and each is a property of the source rather than of the week. FDA's two-week approvals report ran through October 8, so the October 9 pritelivir decision rests on the agency's own approval notice. The monthly 510(k) file was refreshed on October 5 and carries item-level decisions through October 2. The PMA decision feed was rendered the same day, and its newest entry is dated October 3. 101112
At a glance
| Action | FDA date | Indication or intended use | Sponsor | What sets its scale |
|---|---|---|---|---|
| Hovilpri (pritelivir) | Oct. 9 | Mucocutaneous HSV lesions in immunocompromised adults who have exhausted acyclovir, valacyclovir and famciclovir | AiCuris, now part of Asahi Kasei | First therapy approved for refractory HSV; the year's forty-sixth novel drug 12 |
| Juveena Hydrogel System, P250051 | Sep. 28 | Reduce the formation of intrauterine adhesions after hysteroscopic adhesiolysis in adult women | Rejoni | Adhesion-free at week 8 in 61.5% of treated women against 38.2% of controls 913 |
| Autus Size-Adjustable Valve, P260007 | Oct. 1 | Pulmonary valve replacement in children weighing at least 10 kg with a dysfunctional right ventricular outflow tract | Edwards Lifesciences (NYSE: EW) | First approved valve that can be widened as a child grows; formal PMA record now public 8 |
| Jaypirca (pirtobrutinib) | Oct. 2 | Previously untreated CLL or small lymphocytic lymphoma with no known 17p deletion | Eli Lilly (NYSE: LLY) | Progression-free survival hazard ratio 0.20 against chemoimmunotherapy 3 |
| Rhapsido (remibrutinib) | Oct. 6 | Symptomatic dermographism in adults inadequately controlled by H1 antihistamines | Novartis (NYSE: NVS) | First approved treatment for that form of chronic hives 6 |
| Tukysa (tucatinib) | Oct. 7 | Maintenance after induction in unresectable locally advanced or metastatic HER2-positive breast cancer | Seagen, a Pfizer subsidiary (NYSE: PFE) | Median progression-free survival 24.9 against 16.3 months 5 |
| Tecentriq and Tecentriq Hybreza (atezolizumab) | Oct. 8 | Adjuvant treatment of Stage III mismatch repair deficient colon cancer, with a fluoropyrimidine and oxaliplatin | Genentech, a Roche subsidiary | Disease-free survival hazard ratio 0.50 in ATOMIC 4 |
| Weltruza (olanzapine) | Oct. 8 | Schizophrenia in adults | Teva Pharmaceutical Industries (NYSE: TEVA) | First once-monthly subcutaneous olanzapine injection 7 |
New drug approval
Hovilpri is the first drug approved for resistant herpes simplex lesions
FDA approved Hovilpri (pritelivir) tablets on October 9 for adults with weakened immune systems who have mucocutaneous lesions from herpes simplex virus infection and who have not responded to acyclovir, valacyclovir or famciclovir. Mucocutaneous lesions sit on skin or mucosal surfaces — lips, nostrils, eyes, genitals. 2
Herpes simplex virus cannot be cured. It goes dormant and reactivates, and in patients whose immune systems are suppressed by cancer, transplant or HIV it can produce frequent lesions that respond poorly to the standard antivirals. 2
Pritelivir is a direct-acting antiviral with a half-life of about 60 hours, which allows once-daily oral dosing, and it keeps activity against virus that has grown resistant to acyclovir and to foscarnet. 14
FDA based the approval on Part C of the phase 3 PRIOH-1 trial, a randomized, open-label, comparator-controlled superiority study. It enrolled 101 immunocompromised adults with mucocutaneous HSV that had resisted the three standard antivirals. 215
Patients received either pritelivir or the investigator's choice of available treatment for up to 28 days, extended to 42 days where lesions were improving but incomplete. By day 28 all lesions had healed in 63% of patients on pritelivir against 34% on the comparator. Headache was the most common adverse reaction. The FDA notice points clinicians to the prescribing information for drug interactions. 2
The comparator arms were intravenous foscarnet, intravenous or topical cidofovir, or topical imiquimod — options that are off-label, awkward to administer or poorly tolerated. 15
Pritelivir received priority review for this indication, and FDA's novel-drug count places it at number 46 for 2026. 12
Commercial read
The refractory-HSV population is small and the patient is often already inside another expensive illness. In the pivotal trial the underlying immunosuppression came from cancer in 75% of participants, stem cell transplant in 40%, HIV in 38%, autoimmune disease in 29% and solid organ transplant in 4%, with many patients carrying more than one cause. 14
Ownership gives the launch its commercial shape. AiCuris is a German antiviral developer that Asahi Kasei acquired, and Asahi Kasei has said the deal is meant to expand its portfolio against severe viral infections. 1617
For a small-molecule asset approved in an orphan-scale population, the near-term value sits in the label's reach. An immunocompetent indication would move pritelivir from rescue therapy into the far larger genital-herpes market, and the company has been running an expanded access programme for patients with no approved option. 14
New indications and label expansions
Jaypirca moves into first-line CLL
FDA approved pirtobrutinib (Jaypirca) on October 2 for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma who have no known 17p deletion. The October 2 decision reached the agency's approvals report after the previous issue had gone to press, so it is recorded here on its own date. 1018
The supporting trial, BRUIN CLL-313, randomized 282 patients without 17p deletion who had received no prior treatment, one to one, to pirtobrutinib or to bendamustine plus rituximab. At a median follow-up of 28 months, progression-free survival by independent review favored pirtobrutinib with a hazard ratio of 0.20, and median progression-free survival had yet to be reached against 33.5 months for chemoimmunotherapy. Overall response rate was 94% against 81%. 3
Serious adverse reactions occurred in 28% of patients on pirtobrutinib, with pneumonia in 5%, and 4.3% discontinued the drug permanently. The label carries warnings for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, hepatotoxicity and embryo-fetal toxicity. 3
Commercial read
Pirtobrutinib is the only approved non-covalent BTK inhibitor, which is the property its first-line case rests on: it binds both wild-type BTK and the C481-mutated form that covalent inhibitors lose. 3
The commercial opening is timing rather than size. CLL is among the most common adult leukemias, with roughly 22,760 new United States cases expected this year, and Lilly's argument is that many patients will receive only one or two lines of therapy in their lifetime. 3
That argument runs into an established first-line field built on covalent BTK inhibitors and on venetoclax combinations, so the fight is over treatment-naive share rather than over access to a drug that had none. 3
Rhapsido becomes the first approved treatment for symptomatic dermographism
FDA approved remibrutinib (Rhapsido) on October 6 for adults with symptomatic dermographism whose symptoms remain inadequately controlled on H1 antihistamines — the first medicine approved for the condition. Symptomatic dermographism is the most common form of chronic inducible urticaria: skin friction, scratching or rubbing triggers hives and itch. 610
The approval rests on the symptomatic-dermographism cohort of the phase 3 RemIND trial. At week 12, 29.3% of patients on Rhapsido had complete resolution of hives against 14.0% on placebo, with responses appearing as early as week two. The most common adverse events, at 3% or more, were nasopharyngitis, bleeding, headache, nausea and abdominal pain. 6
Rhapsido is an oral, highly selective Bruton's tyrosine kinase inhibitor, already approved for chronic spontaneous urticaria since September 2025. It now holds the only approved uses for the two most common forms of chronic hives. 6
Commercial read
The value here is breadth inside an existing franchise rather than a new launch. For more than half of patients with chronic inducible urticaria, H1 antihistamines leave symptoms uncontrolled, and Rhapsido is the only prescription product indicated for chronic spontaneous urticaria and symptomatic dermographism at once. 6
Novartis is also running remibrutinib in cold urticaria and cholinergic urticaria, and in hidradenitis suppurativa, food allergy and relapsing multiple sclerosis, so the hives label is the base of a much larger development programme. 6
Tukysa takes a maintenance indication in HER2-positive breast cancer
FDA approved tucatinib (Tukysa) on October 7, with trastuzumab and pertuzumab, for maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer after induction treatment. 5
Efficacy came from HER2CLIMB-05, a randomized, double-blind, placebo-controlled trial in 654 adults who had completed four to eight cycles of trastuzumab, pertuzumab and a taxane with no evidence of progression, and who could have brain metastases. Median progression-free survival by investigator assessment was 24.9 months on tucatinib against 16.3 months on placebo, a hazard ratio of 0.64. Overall survival data were immature at the analysis. 5
The label carries a boxed warning for hepatotoxicity, plus warnings for diarrhea, embryo-fetal toxicity and increased serum creatinine without a change in renal function. The recommended dose is 300 mg twice daily. 5
Tecentriq adds an adjuvant colon-cancer indication
FDA approved atezolizumab (Tecentriq) on October 8, with a fluoropyrimidine and oxaliplatin, for adjuvant treatment of Stage III mismatch repair deficient colon cancer in adults and in children two years and older. The subcutaneous form, atezolizumab and hyaluronidase-tqjs, was approved the same day for patients 12 and older weighing at least 40 kg. 4
Efficacy came from ATOMIC, a randomized, open-label, active-controlled trial in 711 adults and one pediatric patient with Stage III mismatch repair deficient colon cancer after complete resection of the primary tumor. Patients received atezolizumab with mFOLFOX6 followed by atezolizumab alone, or mFOLFOX6 alone. 4
The hazard ratio for disease-free survival was 0.50, and median disease-free survival was not reached in either arm. The review ran under Project Orbis with the Australian, Canadian, Israeli and Swiss regulators, and both applications received priority review. 4
Mismatch repair deficiency describes tumors that cannot repair errors in their DNA, a state that makes them unusually visible to checkpoint inhibitors. It appears in a minority of colon cancers, and Stage III disease is the setting where surgery alone leaves a high chance of recurrence. 4
New formulations
Weltruza makes olanzapine a monthly subcutaneous injection
FDA approved Weltruza (olanzapine) extended-release injectable suspension on October 8 for schizophrenia in adults — the first once-monthly subcutaneous long-acting injectable of olanzapine. It comes in three strengths, 318 mg, 425 mg and 531 mg, corresponding to oral doses of 10 mg, 15 mg and 20 mg. 710
The formulation's selling points are procedural. Teva states that Weltruza needs no loading doses, no oral supplementation and no post-injection monitoring, and that patients reach therapeutic blood levels without oral cotreatment or booster injections. 7
Olanzapine has been the most widely prescribed atypical antipsychotic for schizophrenia as a daily oral treatment. Adherence is the problem the injectable form is meant to solve, since lapses in daily dosing raise the risk of relapse. Teva estimates about 2.1 million people in the United States are diagnosed with schizophrenia. 7
The approval rests on the phase 3 SOLARIS trial. All three doses were similarly tolerated, with the most common adverse events being increased weight, somnolence, headache, constipation and injection site reactions; discontinuations for common adverse events were 5% against 4% on placebo. Weight gain and metabolic change were consistent with oral olanzapine. 7
Teva warns that post-injection delirium/sedation syndrome has occurred with an intramuscular extended-release olanzapine, and states that whether it can occur with a subcutaneous product is unknown. The drug uses SteadyTeq copolymer technology licensed from Medincell, and Teva expects United States availability within weeks. 7
Commercial read
Long-acting injectables are the segment where an antipsychotic franchise is won or lost, and olanzapine has been an odd gap: widely used orally, and until now available as a long-acting injection only through an intramuscular product carrying a monitoring requirement. A subcutaneous once-monthly version removes that friction. Teva frames the approval inside its Pivot to Growth strategy and a differentiated long-acting injectable franchise. 7
Breztri Aerosphere adds an original application
FDA's October 8 report also records an original application, NDA 220290, for Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate) from AstraZeneca, classified as a new formulation or new manufacturer. Breztri is a single-inhaler triple therapy already approved for chronic obstructive pulmonary disease and, since April 2026, for asthma in patients 12 and older. 10
The agency's report gives the classification and the approval without describing what changed in this application, so the specific change is pending a look at the product's own documentation. 10
Other captured drug actions
The week's remaining original applications were generics, plus one tentative approval carried over from October 1. 10
| Application | Product | Dosage form | Applicant | Date | Category |
|---|---|---|---|---|---|
| ANDA 220492 | Perampanel | Tablet | Aurobindo Pharma Ltd | Oct. 2 | Generic |
| ANDA 218725 | Solriamfetol | Tablet | Aurobindo Pharma Ltd | Oct. 6 | Generic |
| ANDA 215701 | Sugammadex sodium | Solution, intravenous | Shandong | Oct. 6 | Generic |
| ANDA 219737 | Fidaxomicin | Tablet | Hikma Pharms | Oct. 7 | Generic |
| ANDA 218248 | Hydrochlorothiazide | Solution, oral | Rubicon Research | Oct. 7 | Generic |
| ANDA 219599 | Mirabegron | Tablet, extended release | Creekwood Pharms | Oct. 7 | Generic |
| ANDA 218832 | Pitolisant | Tablet | Annora Pharma | Oct. 8 | Generic |
| NDA 219007 | Weltruza (olanzapine) | Injectable suspension | Teva Neuroscience | Oct. 8 | New formulation |
| NDA 220290 | Breztri Aerosphere | Inhalant | AstraZeneca | Oct. 8 | New formulation |
A class-wide REMS action ran on October 7 across the isotretinoin market: FDA's report lists REMS supplements for Absorica, Absorica LD, Amnesteem, Claravis, Myorisan, Zenatane and eight generic isotretinoin applications from Actavis, Amneal, Zydus, Upsher-Smith and Aurobindo. Isotretinoin carries a high risk of fetal injury, so all of these products operate under the iPLEDGE risk evaluation and mitigation strategy, whose modification FDA approved in February 2026 and delayed to November 15, 2026 for system testing. 1019
Medical devices
Two original PMA approvals, and the valve record that finally arrived
The PMA decision feed, rendered October 5, carried two original approvals dated inside this window. 12
The first, P250051, approved September 28, is the Juveena Hydrogel System from Rejoni. It is indicated for adult women, to reduce the incidence and severity of intrauterine adhesion formation after hysteroscopic adhesiolysis for symptomatic moderate to severe adhesions. A companion Rejoni Acorn Catheter delivers the hydrogel into the uterine cavity. The advisory committee was obstetrics and gynecology, and the pivotal study is NCT05394662. 9
Intrauterine adhesions form after trauma to the lining of the uterus and can cause menstrual disruption, infertility, recurrent pregnancy loss and obstetric complications, and they commonly return after surgical removal. The pivotal study randomized women two to one to Juveena or surgery alone at 15 United States centers and used a second-look hysteroscopy about eight weeks later. In the labeled population, 61.5% of treated women were adhesion-free at week eight against 38.2% of controls, and severe adhesions appeared in 6.1% of treated women against 28.6% of controls. Device-attributed adverse events occurred in 8% of treated patients, all non-serious. The hydrogel forms in place, separates the uterine walls, and is discharged over roughly 14 to 21 days. 13
Rejoni raised $25 million earlier this year for commercialization and plans a limited release at selected centers before a wider rollout, with a patient access program for coverage and reimbursement. 13
The second original approval, P260007, dated October 1, is the Autus Size-Adjustable Valve from Edwards Lifesciences — the pediatric pulmonary valve the previous issue reported from FDA's press announcement. The record now confirms it as an original premarket approval and supplies the formal indication: pediatric patients weighing at least 10 kg who need surgical pulmonary valve replacement for a dysfunctional native or surgically repaired right ventricular outflow tract, defined by severe pulmonary stenosis with a peak gradient of at least 60 mmHg, at least moderate pulmonary regurgitation, or both at least moderate stenosis and at least moderate regurgitation. 8
The captured 510(k) ledger
The downloadable 510(k) file was refreshed on October 5 and now carries item-level decisions dated September 1 through October 2. That refresh added 67 clearances dated September 28 through October 2, closing the gap the previous issue had flagged, which ran only through September 27. 11
The names inside those 67 are mostly instruments, implants, monitors and diagnostics, and several belong to large manufacturers. 11
| K number | Device | Applicant | FDA decision |
|---|---|---|---|
| K261612 | SwiftSight Body Composition, MRI-based body-composition software | AIRS Medical | Oct. 1 |
| K263016 | Intra-Operative Positioning System and IOPS Visionary System | Centerline Biomedical | Oct. 1 |
| K262473 | NEXUS Hip Stem | MicroPort Orthopedics | Oct. 1 |
| K260283 | VITEK 2 AST-Streptococcus Meropenem susceptibility test | bioMerieux | Oct. 1 |
| K261933 | Voluson Expert 18, 20 and 22 ultrasound systems | GE Medical Systems Ultrasound | Oct. 2 |
| K261042 | Lung Guidance, ultrasound software | GE Medical Systems Ultrasound | Oct. 2 |
| K261783 | Plenity-V oral hydrogel | Gelesis | Oct. 2 |
| K263120 | Xpert Xpress CoV-2/Flu plus | Cepheid | Oct. 2 |
| K260490 | Ninenovo Blood Oxygen Ring | Shenzhen Ninenovo Technology | Oct. 2 |
| K260221, K260232, K260233 | Elecsys EBV EBNA IgG, EBV VCA IgG and EBV IgM assays | Roche Diagnostics | Oct. 2 |
| K261791 | MEDIVATORS ADVANTAGE NXT automated endoscope reprocessor | Steris | Oct. 2 |
| K260044 | Ventricular catheters and Thomale catheter | Aesculap | Oct. 2 |
Device records on FDA's public surfaces carry the applicant and the decision date, and describe the cleared scope in the applicant's own wording, so the intended use of a fresh clearance rests on what the applicant announced. 11
Clearances reported this week, on earlier FDA dates
Several companies announced clearances between October 5 and October 9 whose FDA decision dates, where the captured file shows them, are earlier than the announcement — the pattern this channel has recorded for weeks.
| Device | Applicant | Announced | FDA date in the captured file |
|---|---|---|---|
| SwiftSight Body Composition, K261612 | AIRS Medical | Oct. 5 | Oct. 1 2021 |
| Liora Monofilament Scaffold, K260474 | TELA Bio | Oct. 8 | Sep. 28 2223 |
| S-Patch CardioAI, K254255 | Wellysis | Oct. 8 | Sep. 25 2425 |
| NextMR, K260525 | MRI2CT | Oct. 7 | Sep. 4 2627 |
| MyoVista wavECG Device | HeartSciences | Oct. 6 | not yet in the file 28 |
| OpenFlo Catheter | Urolution Medical | Oct. 9 | not yet in the file 29 |
What matters next
- The device ledger for October 3 through 9. The next issue should pick up 510(k) decisions dated October 3 or later and any PMA decision after October 3, once the monthly file and the feed are refreshed.
- Hovilpri's launch and label reach. AiCuris has an expanded access programme running and an immunocompetent programme discussed publicly; watch whether the sponsor files there, and how payers treat a rescue antiviral in patients who are already expensive to treat.
- Jaypirca's treatment-naive share. The first-line CLL field is built on covalent BTK inhibitors and venetoclax combinations, so uptake will show whether the resistance-breaking mechanism converts into prescribing preference at diagnosis.
- Weltruza's reception against existing long-acting injectables. Teva's clinical claim rests on removing monitoring and oral cotreatment, and the subcutaneous route's post-injection syndrome risk remains unquantified in the label.
- Tecentriq's read-through in colorectal cancer. An adjuvant checkpoint benefit in mismatch repair deficient Stage III disease raises the question of how the perioperative regimens now in development will be positioned against it.
References
- 1
- 2
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- 7Teva Announces U.S. FDA Approval of WELTRUZA
biospace.com
- 8FDA PMA record P260007, Autus Size-Adjustable Valve
accessdata.fda.gov
- 9FDA PMA record P250051, Juveena Hydrogel System
accessdata.fda.gov
- 10Recent New and Generic Drug Approvals
accessdata.fda.gov
- 11Downloadable 510(k) Files
fda.gov
- 12FDA PMA Decisions Feed
accessdata.fda.gov
- 13Rejoni Receives FDA Approval of the Juveena Hydrogel System
morningstar.com
- 14
- 15FDA approves pritelivir tablets to treat lesions from HSV
contemporaryobgyn.net
- 16Asahi Kasei Completes Acquisition of AiCuris
asahi-kasei.com
- 17Asahi Kasei to buy Germany's AiCuris for $920M
fiercebiotech.com
- 18
- 19
- 20
- 21FDA 510(k) record K261612
accessdata.fda.gov
- 22
- 23FDA 510(k) record K260474
accessdata.fda.gov
- 24
- 25FDA 510(k) record K254255
accessdata.fda.gov
- 26MRI2CT Receives FDA 510(k) Clearance for NextMR
finance.yahoo.com
- 27FDA 510(k) record K260525
accessdata.fda.gov
- 28
- 29
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