FDA approvals: the first DNA medicine, Talzenna's earlier line and Ilumya in arthritis lead the Oct. 24–30 ledger
A date-bounded ledger of the FDA's October 24–30, 2026 decisions, led by the first DNA medicine approved in the United States, a PARP-inhibitor combination moved into hormone-sensitive prostate cancer, and an IL-23 antibody's first arthritis label.
The FDA granted accelerated approval to Inovio's Voceryq on October 30 for adults with recurrent respiratory papillomatosis. 1 Inovio calls it the first DNA medicine the agency has approved in the United States. 1
This ledger covers FDA decisions dated October 24 through 30, 2026. The disease fills the airway and voice box with wart-like growths, mostly from HPV types 6 and 11, and surgery is the standard treatment because the growths return. 1
Three other products changed position in the same seven days. Pfizer moved a PARP-inhibitor combination into an earlier prostate-cancer line, Sun Pharma added a first arthritis indication to an IL-23 antibody, and Xbrane Biopharma cleared a ranibizumab biosimilar. 234
Each of the three federal surfaces has its own cutoff, and those cutoffs set what this ledger can see. 5 FDA's two-week drug report carried entries through October 30, starting October 21. 5
The monthly 510(k) file reached October 23, and the PMA decision feed, rendered October 27, carried no decision later than October 25. 67 No official item-level device record exists yet for October 26–30, so the device actions in those five days appear below as the companies announced them.
At a glance
| Action | FDA date | Indication or intended use | Sponsor | What sets its scale |
|---|---|---|---|---|
| Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) | Oct. 30 | Adults with recurrent respiratory papillomatosis, to reduce the frequency of surgical papilloma excisions | Inovio Pharmaceuticals (NASDAQ: INO) | Seven of 26 treated patients needed no surgery in the following 12 months 1 |
| Talzenna (talazoparib) with Xtandi (enzalutamide) | Oct. 26 | Metastatic hormone-sensitive prostate cancer with HRR gene mutations, detected by an authorized test | Pfizer (NYSE: PFE) | Risk of progression or death cut 52%; median rPFS not reached against 45.8 months 2 |
| Ilumya (tildrakizumab-asmn) | Oct. 29 | Adults with active psoriatic arthritis | Sun Pharmaceutical Industries (NSE: SUNPHARMA) | 2.4 million Americans with the disease; the company disclosed no response rates 3 |
| Ultomiris (ravulizumab) | Oct. 21 | IgA nephropathy, to reduce proteinuria in adults at risk of progression | Alexion, AstraZeneca Rare Disease | 43.4% placebo-adjusted proteinuria reduction at week 34; carried over from the previous window 8 |
| Lucamzi (ranibizumab-blrz) | Oct. 27 | Biosimilar to Lucentis, for the reference product's retinal uses | Xbrane Biopharma (Nasdaq Stockholm: XBRANE) | A second ranibizumab source in a market Xbrane sizes at about €9 billion a year 4 |
| Embrace hydrogel embolic, expanded indication | Announced Oct. 29 | Embolization of peripheral arterial bleeds in vessels 6 mm or smaller | Instylla | 90.0% clinical success at 30 days in 130 patients; no official record yet 9 |
| Elecsys HBsAg II quant II RxDx | Oct. 20 | De Novo classification of a quantitative hepatitis B surface antigen assay | Roche Diagnostics | The assay FDA named as the companion diagnostic for Hibsago 1011 |
Voceryq: a DNA injection aimed at the virus behind the growths
Voceryq is a plasmid DNA immunotherapy. 1
The plasmids carry instructions for HPV-6 and HPV-11 antigens, and the body's cells read them and produce the proteins the immune system learns to attack. 1
Delivery uses Inovio's CELLECTRA 5PSP device, which applies an electric field to open the cells to the DNA. 1
Patients first have visible papilloma removed surgically, then receive the nine-week regimen. 1 No further surgery is scheduled during dosing. 1
The approval is accelerated and rests on one measure: no surgical excision of papilloma in the 12 months after treatment. 1
The supporting study, RRP-001, enrolled 32 adults who had at least two surgeries in the year before treatment. 1 The efficacy group was the 26 of them with three or more prior excisions. 1
Those 26 had a median of 4.5 excisions in the previous year, ranging from 3 to 8. 1 Seven of the 26, or 27% with a 95% confidence interval of 12% to 48%, went 12 months without surgery. 1
Reactions above 5% were injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness. 1 Most were mild or moderate and all 32 patients finished the study. 1
The label warns about injection-site reactions and about effects of the electrical delivery, including muscle contractions and fainting. 1 It tells clinicians to avoid sites with a pacemaker, metal implant or damaged skin on the same side. 1
FDA had already granted Orphan Drug and Breakthrough Therapy designations. 1
Commercial read
Inovio estimates at least 25,000 people in the United States have the disease, based on its own analysis of claims data. 1
This is Inovio's first approved product, and investors priced it that way: the shares rose 286% in after-hours trading. 12
Its closest competitor reached the market first. Precigen's Papzimeos was approved in 2025 as the first medicine for the disease. 12 Papzimeos uses a modified virus to provoke the immune response; Voceryq uses DNA. 12 Both are aimed at HPV 6 and 11. 12
Inovio will sell the product on its own in the United States, with Syneos Health supplying the field teams. 1 The company expects to take orders and ship in about 60 days, with full field deployment in the first quarter of 2027. 1
Inovio has not published a price. 1 Without a price, the revenue side of the model stays open.
Two features of the evidence shape the commercial case. The 27% comes from seven patients, so the confidence interval runs from 12% to 48%. 1 The study was single-arm, so the comparison is against the disease's usual course, which the company describes as returning growths needing repeat surgery. 1
The FDA requires a confirmatory study: a draft protocol by the end of 2026 and an agreed final protocol by roughly mid-2027. 1
Clinicians already have a surgical default and, since 2025, a viral-vector alternative. 12 Adoption will turn on whether a nine-week course with an electroporation device fits an office that treats a few of these patients. How payers treat a treatment given once is the second unknown. Neither has been disclosed.
Talzenna: a PARP combination moves one line earlier
On October 26 the FDA approved Talzenna with Xtandi for adults with metastatic prostate cancer. The cancer must still respond to hormone treatment, and it must carry a homologous recombination repair, or HRR, gene mutation. 2
The agency's term for this stage is metastatic androgen pathway modulation-naïve or -sensitive; Pfizer calls the same group metastatic hormone-sensitive prostate cancer. 13
Talzenna is an oral PARP inhibitor and Xtandi an androgen receptor pathway inhibitor. 13 The pair was first approved in June 2023 for the castration-resistant stage of the same mutation-defined group. 13
The trial behind the new indication, TALAPRO-3, randomized 599 patients one-to-one to enzalutamide with either talazoparib or placebo. 2 Everyone also received continuous androgen deprivation therapy. 2
Eligibility required a mutation in one of 12 genes, including BRCA1, BRCA2, ATM, CDK12 and PALB2, found by tumor tissue or blood testing. 2
Median radiographic progression-free survival was not reached on the combination, against 45.8 months on enzalutamide alone. 2 The hazard ratio was 0.48, with a 95% confidence interval of 0.36 to 0.65. 2 Overall survival data were immature when the analysis closed. 2
Pfizer reports that an estimated 77% of patients remained free of progression at three years. 13 The benefit held for patients with BRCA mutations and for those with other HRR mutations. 13
Dosing is 0.5 mg of talazoparib once daily with enzalutamide, alongside a GnRH analogue or after surgical castration. 2
The cost is blood. Grade 3 or worse anemia reached 51% on the combination against 3% on the control arm, and 5% of patients stopped talazoparib because of it. 13 The label carries a warning for myelodysplastic syndrome and acute myeloid leukemia, seen in about 1% of 1,096 patients across talazoparib studies. 13
FDA approved the companion tests earlier: FoundationOne CDx and FoundationOne Liquid CDx. 2
Review ran under Priority Review and under Project Orbis with Australia's TGA and Health Canada, whose reviews continue. 2
Commercial read
Pfizer puts HRR mutations in about 25% of patients at this stage. 13
The addressable population therefore starts with testing. A patient whose tumor is never sequenced cannot be routed to the combination, and the treatment decision now sits at diagnosis, when tissue may be scarce. 13
Pfizer shares Xtandi with Astellas in the United States, so the value of moving the combination earlier splits between the two companies. 13 Astellas reports more than 1.5 million patients treated with Xtandi worldwide. 13
Immature survival data limits what payers can be shown. Progression-free survival is the endpoint on the label; a price premium usually needs the overall-survival readout, which will arrive later. 2
The anemia profile matters in this population, which is older and often has other reasons for low blood counts. Monthly blood monitoring is in the label. 13
Ilumya: a first arthritis label, with the efficacy figures unpublished
The FDA record for Sun Pharma's supplement is dated October 29; the company announced the approval the next morning. 35
Ilumya is tildrakizumab, an antibody that blocks the p19 subunit of interleukin-23, a signalling protein that drives inflammation. 3 FDA approved it in 2018 for moderate-to-severe plaque psoriasis; the new use is active psoriatic arthritis in adults. 3
The supporting studies were INSPIRE-1 and INSPIRE-2, 52-week placebo-controlled trials of tildrakizumab 100 mg. 3 INSPIRE-1 enrolled patients previously exposed to a TNF inhibitor, INSPIRE-2 those who were not, and together they ran past 800 patients. 14
The primary endpoint was the share of patients reaching a 20% improvement on the American College of Rheumatology scale at week 24. 14 Sun Pharma said in 2025 that both trials met it. 14
The October 30 announcement carried no response rates, no secondary endpoints and no results split by prior TNF exposure. 14
Safety was reported as consistent with the drug's existing profile, with no new signals. 3 The most common reactions in the arthritis trials were upper respiratory infections and COVID-19, and patients need tuberculosis screening first. 3
Commercial read
Sun Pharma positions the product as the IL-23 option given by a health care provider, for patients who cannot inject themselves at home or who benefit from in-office care. 3
The franchise it is joining is small next to the disease. Sun puts 2.4 million Americans with psoriatic arthritis, about one in three people with psoriasis, and flags that more than 15% of psoriasis patients may have it undiagnosed. 3
Sun's global innovative medicines business recorded $1.42 billion in sales for the year to March 2026, up 16.4% excluding milestone income. The fourth quarter contributed $354 million, up 20.1%. 15 The company says its US innovative medicines revenue has passed $1 billion. 15
The filing itself slipped. Sun's results materials listed a US goal date of October 26 for this supplement, and FDA acted on October 29. 515
Two questions for the launch have no public answer yet: whether the in-office model carries a price premium, and how payers treat a provider-administered IL-23. 14 Self-injected alternatives exist for the same disease, including TNF inhibitors and targeted synthetic drugs. 14
The phase 2b study in this disease set a caution flag the company has not yet addressed. A higher-than-expected placebo response muddied the result, and improvements in dactylitis (swollen digits) and enthesitis (inflamed tendon attachments) did not appear. 14
Lucamzi: a second source for a drug ophthalmologists use heavily
Xbrane Biopharma won approval on October 27 for Lucamzi, a biosimilar to Lucentis whose active ingredient is ranibizumab. 16 Ranibizumab blocks vascular endothelial growth factor, the protein that makes abnormal vessels leak in the retina. 4
The submission rested on a structural and functional comparison with the reference product plus a phase 3 study in 582 patients with wet age-related macular degeneration. 4 That study showed equivalent efficacy and comparable safety. 4
Xbrane will prepare the US launch during 2027 with its partners. 4
Commercial read
Anti-VEGF drugs for retinal disease make up a market of roughly €9 billion in annual net sales, on about 10 million injections a year, by Xbrane's own figures. 4
Xbrane cites about 20 million people in the United States living with age-related macular degeneration and puts the economic burden of late-stage disease at $49.4 billion a year. 4
A biosimilar's commercial case rests on price, and Xbrane's release states the argument without numbers: more competition on ranibizumab lowers cost and widens access. 4
The launch date is far enough out that the pricing and contracting terms that decide share will not be known this fiscal year. 4
Carried over: Ultomiris becomes the first C5 inhibitor for IgA nephropathy
The FDA approved Ultomiris on October 21, inside the previous window, and it is recorded here with that date. 5
On October 21 the FDA granted accelerated approval to Ultomiris, or ravulizumab, to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of progression. 17 It is the first C5 inhibitor cleared for that use and the fifth indication for the drug. 8
In the I CAN trial's interim analysis, 24-hour urine protein fell 46.6% from baseline at week 34 on Ultomiris and 5.6% on placebo, a placebo-adjusted reduction of 43.4%. 8 The effect appeared by week 10 and held through week 34. 8
Dosing is intravenous every eight weeks after a loading dose. 8 Full approval depends on the trial's week-106 kidney-function endpoint, which is still running. 8
IgA nephropathy affects more than 200,000 people in the United States. About half of those with elevated protein or reduced kidney function reach kidney failure within 10 years of diagnosis. 8
Two further supplements in that earlier stretch are named in FDA's public report without a stated change: a risk-management supplement for Soliris and an efficacy supplement for Monoferric. 5 The report does not state what changed in either, so their effect has to be read from the labels on Drugs@FDA.
Devices: the official ledger catches up on October 19–25
The refreshed 510(k) file carries 63 decisions dated October 19 through 23, and one of them is a De Novo classification rather than a clearance. 6 The PMA feed, rendered October 27, adds 48 decisions dated October 19 through 25, all of them supplements to existing approvals. 7 No original PMA was approved in that stretch.
The De Novo ties to the hepatitis B approval from the week before. 10 Roche Diagnostics received classification on October 20 for the Elecsys HBsAg II quant II RxDx, the quantitative hepatitis B surface antigen assay. 10 When FDA approved GSK's Hibsago on October 20, it named this assay as the companion diagnostic for choosing and monitoring patients. 11 Roche filed on June 2, 2026. 10
Ten of those clearances show what the file added.
| Product | Applicant | Record | FDA date | What the record covers |
|---|---|---|---|---|
| SafeAir electrosurgical generator with smoke evacuation | Stryker Instruments | K262386 | Oct. 20 | An electrosurgical generator with built-in smoke evacuation 6 |
| Accuro XV | Rivanna Medical | K262093 | Oct. 20 | An ultrasound system for procedural guidance 6 |
| Versius surgical system | CMR Surgical | K261252 | Oct. 21 | A robot-assisted surgical system 6 |
| AtriClip FLEX-Mini LAA exclusion system | AtriCure | K263319 | Oct. 21 | A clip that excludes the left atrial appendage 6 |
| Toro 71 aspiration catheter and tubing | Toro Neurovascular | K262021 | Oct. 21 | An aspiration catheter and its connecting tubing 6 |
| Calibrate MAX and CCX interbody systems | Alphatec Spine | K262646 | Oct. 21 | Interbody devices for spinal fusion 6 |
| Veritas shoulder system | restor3d | K263421 | Oct. 22 | A shoulder implant system 6 |
| VENTANA MMR IHC panel | Roche Tissue Diagnostics | K260776 | Oct. 23 | A staining panel for mismatch repair proteins in tumor tissue 6 |
| DLP left heart vent catheters | Medtronic | K261792 | Oct. 23 | Catheters used to vent the left heart during surgery 6 |
| STAR Apollo mapping system | Rhythm AI | K263380 | Oct. 23 | A cardiac mapping system 6 |
Two device actions were announced inside this week's window with no official record behind them yet.
Instylla won an expanded indication on October 29 for its Embrace hydrogel embolic system, extending it from hypervascular tumors to peripheral arterial bleeds in vessels 6 mm or smaller. 9 The supporting study, HALT, enrolled 130 patients with arterial bleeds at 22 US sites. It met both primary endpoints, with freedom from major adverse events in 100% of patients and 90.0% clinical success at 30 days. 9 The hydrogel dissolves by hydrolysis over about 11 months. 9
SEKISUI Diagnostics said on October 27 that its OSOM COVID-19/Flu A&B Combo Test has 510(k) clearance, a lateral-flow test for use in professional settings and waived for point-of-care use. 18 The company is positioning it for labs as the emergency-use authorization pathway for such tests winds down. 18
Other drug actions, October 24–30
| Application | Product | Applicant | FDA date | Action |
|---|---|---|---|---|
| NDA 220748 | Cisplatin, liquid | Avyxa Holdings | Oct. 29 | Original application, new formulation 5 |
| ANDA 220400 | Epinephrine injection | Gland Pharma | Oct. 26 | Generic original 5 |
| ANDA 216072 | Propranolol hydrochloride tablets | Senores Pharmaceuticals | Oct. 26 | Generic original 5 |
| ANDA 217267 | Valganciclovir hydrochloride oral solution | Alembic | Oct. 26 | Generic original 5 |
| ANDA 220384 | Tivozanib capsules | Somerset Therapeutics | Oct. 26 | Tentative approval 5 |
| ANDA 212247 | Rivaroxaban tablets | Teva Pharmaceuticals USA | Oct. 27 | Generic original 5 |
| ANDA 221213 | Tranexamic acid tablets | Zydus Lifesciences | Oct. 27 | Generic original 5 |
| ANDA 221339 | Ivacaftor tablets | MSN Laboratories | Oct. 27 | Tentative approval 5 |
| NDA 214801 | Lytgobi (futibatinib) | Taiho Oncology | Oct. 27 | Labeling 5 |
| NDA 216490 | Yorvipath (palopegteriparatide) | Ascendis Pharma | Oct. 27 | Labeling 5 |
| ANDA 216722 | Fulvestrant injection | Sinopep Allsino | Oct. 28 | Generic original 5 |
| ANDA 220602 | Ketamine hydrochloride injection | Neurorx | Oct. 28 | Generic original 5 |
| ANDA 220782 | Triamterene capsules | Rubicon Research | Oct. 28 | Generic original 5 |
| ANDA 214747 | Venetoclax tablets | Alembic | Oct. 28 | Generic original 5 |
| NDA 212526 | Piqray (alpelisib) | Novartis | Oct. 28 | Labeling 5 |
| NDA 019763 | Ifex (ifosfamide) | Baxter Healthcare | Oct. 28 | Labeling 5 |
One action touched an entire drug class. 5 On October 27 the FDA approved risk-management supplements for bosentan, covering Actelion's Tracleer and seven generic versions. 5
A risk evaluation and mitigation strategy, or REMS, is FDA's tool for restricting how a drug reaches patients when ordinary labeling is judged insufficient. 5 The public report names the action and not the change, so what the bosentan program now requires has to be read from the approved materials.
Tentative approvals are FDA's signal that a generic has cleared its scientific review and waits on patent or exclusivity before it can be sold. 5
What matters next
Inovio owes the FDA a draft protocol for Voceryq's confirmatory study by the end of 2026, with an agreed final version around mid-2027. 1 The company's own timeline puts product in customers' hands within about 60 days and a full field force in the first quarter of 2027. 1
Talzenna's overall-survival readout is the number to watch, and the European Medicines Agency is still reviewing the same application. 13
Sun Pharma has said full INSPIRE results will be presented and published, which is when the psoriatic arthritis label's actual effect size becomes visible. 14
Ultomiris moves from accelerated to full approval only if the I CAN trial's week-106 kidney-function endpoint holds. 8
Xbrane plans its US launch during 2027, and the pricing that decides whether a biosimilar takes share will appear before then. 4
References
- 1
- 2
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- 4
- 5Recent New and Generic Drug Approvals
accessdata.fda.gov
- 6Downloadable 510(k) Files
fda.gov
- 7FDA PMA Decisions Feed
accessdata.fda.gov
- 8
- 9
- 10De Novo record DEN260027, Elecsys HBsAg II quant II RxDx
accessdata.fda.gov
- 11
- 12
- 13
- 14
- 15Sun Pharma reports Q4 and full year results for FY26
sunpharma.com
- 16Drugs@FDA application record for BLA 761187, ranibizumab
accessdata.fda.gov
- 17
- 18
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