PETAH TIKVA (dpa-AFX) - The following comprises a list of drugs that received approval from the U.S. Food and Drug Administration (FDA) in October 2026.
October's FDA approvals brought new treatment options across a range of conditions. These included an over-the-counter eye drop for redness caused by minor irritation, a once-monthly injection offering an alternative to a daily schizophrenia pill, an oral antiviral for hard-to-treat herpes simplex lesions, and a DNA-based immunotherapy that received accelerated approval for a rare airway disorder, to name a few.
What changes for patients when an already approved drug comes in a new form, or when a new treatment arrives after standard options have failed? Here's a closer look at the evidence, how the drugs compare with existing options, and what's known about their U.S. prices.
1. Weltruza (olanzapine)
Developed by: Teva Pharmaceutical Industries Ltd. (TEVA)
Approved on: October 8, 2026
Indication: Schizophrenia in adults
Schizophrenia can cause hallucinations, delusions and disorganized thinking. Difficulty taking daily medication can increase the risk of relapse. Teva estimates that 2.1 million people in the U.S. have been diagnosed with schizophrenia.
Weltruza is injected under the skin once a month. Its SteadyTeq technology gradually releases olanzapine. Treatment requires no loading dose, supplemental oral olanzapine or routine observation after injection.
Olanzapine's therapeutic effect is thought to involve blocking dopamine and serotonin receptors. Weltruza comes in 318 mg, 425 mg and 531 mg doses, corresponding to daily oral olanzapine doses of 10 mg, 15 mg and 20 mg. Tolerability to oral olanzapine must be established before treatment begins.
The approval was based on results from the pivotal Phase 3 SOLARIS trial that randomized 675 adults with schizophrenia. At eight weeks, all three doses met the primary endpoint: symptom scores on the Positive and Negative Syndrome Scale fell by 9.7 to 11.3 points more than with placebo. Illness severity and personal and social functioning also improved.
Common adverse reactions included weight gain, sleepiness, headache, constipation and injection-site reactions.
Teva reported a U.S. wholesale acquisition cost (WAC) of $3,950 per monthly dose, before rebates or discounts.
Competitors:
Drug | Developer | Indication | |
|---|---|---|---|
Zyprexa Relprevv (olanzapine pamoate) | Eli Lilly (LLY) | Schizophrenia; intramuscular injection every two or four weeks | |
Uzedy (risperidone) | Teva Pharmaceuticals (TEVA)/ MedinCell S.A. (MEDCL.PA) | Schizophrenia in adults; subcutaneous injection monthly or every two months |
Stock Quote: TEVA has been trading in a range of $23.98 and $43.34 in the last 1 year. The stock closed Tuesday at $42.40, down 1.33%.
2. Hovilpri (pritelivir)
Developed by: Asahi Kasei Corp. (3407.T)
Approved on: October 9, 2026
Indication: Refractory Herpes simplex virus (HSV) lesions
Herpes simplex is a lifelong infection that can flare up and cause painful lesions. In people with weakened immune systems, lesions can persist despite standard antiviral treatment and may require intravenous therapy. Hovilpri adds an oral option.
AiCuris, now part of Asahi Kasei Therapeutics, developed Hovilpri for immunocompromised adults with HSV lesions on the skin or mucous membranes that have not responded to acyclovir, valacyclovir or famciclovir. The approval applies whether or not drug resistance has been documented.
Hovilpri blocks helicase-primase, an enzyme complex HSV requires to copy its DNA. The recommended oral dose is 400 mg on day one, followed by 100 mg once daily until the lesions heal.
In the pivotal Phase 3 PRIOH-1 trial of 101 immunocompromised adults, 63% of Hovilpri recipients achieved complete lesion healing by day 28, compared with 34% on investigator-selected treatment.
Adverse reactions led 2% of Hovilpri recipients and 20% of those receiving investigator-selected treatment to discontinue treatment. Headache was the most common adverse reaction with Hovilpri.
Asahi Kasei expects Hovilpri to be available in the U.S. by the end of 2026. The company did not disclose a U.S. WAC in its approval announcement.
Competitors:
Drug | Developer | Indication | |
|---|---|---|---|
Foscavir (foscarnet sodium) | Clinigen (U.S. labeler) | Intravenous treatment for acyclovir-resistant HSV lesions immunocompromised patients | |
Valtrex (valacyclovir) | GSK Plc (GSK) | Cold sores; genital herpes treatment and suppression | |
Abreva (docosanol) - Over-the-counter topical product | Haleon | Cold sores on the lips or face in people aged 12 and older |
Stock Quote: Asahi Kasei Corp shares have been trading on the Tokyo Stock Exchange between JPY 1,247 and JPY 1,906 over the past 1 year. The shares closed up 1.20% on Tuesday at JPY 1,599.50.
3. Brytly (apraclonidine)
Developed by: Alcon AG (ALC)
Approved on: October 16, 2026
Indication: Eye redness from minor irritation
Dryness or dust can dilate blood vessels on the surface of the eye, making it look red. Brytly, approved for eye redness from minor irritation, is the first over-the-counter (OTC) eye drop to contain apraclonidine, an ingredient already used at higher concentrations in prescription drops to lower eye pressure.
Brytly contains 0.125% apraclonidine, which stimulates alpha-adrenergic receptors and narrows blood vessels on the eye's surface. The label directs adults and children aged 12 and older to use one drop in each affected eye no more than twice daily.
The FDA approved Brytly under the 505(b)(2) pathway. Alcon reported that a single drop reduced redness within one minute and that the effect lasted up to 12 hours. The company also reported a low risk of rebound redness or reduced effectiveness with repeated use as directed.
Alcon expects Brytly to reach major U.S. retailers and online stores in the coming months. The company did not disclose a U.S. WAC in its approval announcement.
Competitors:
Drug | Developer | Indication | |
|---|---|---|---|
Lumify (brimonidine tartrate 0.025%) | Bausch + Lomb Corp (BLCO) | Eye redness from minor irritation | |
Fluorometholone ophthalmic 0.1% solution | Multiple generic manufacturers | Prescription treatment for steroid-responsive eye inflammation |
Stock Quote: ALC has ranged between $61.83 to $87.64 per share in the past year. Shares closed Tuesday down 1.44% at $74.06.
4. Hibsago (Bepirovirsen)
Developed by: GSK plc (GSK) and Ionis Pharmaceuticals Inc. (IONS)
Approved on: October 20, 2026
Indication: Chronic Hepatitis B
Hepatitis B is a viral infection leading to acute and chronic disease, often leading to liver cirrhosis or cancer. Chronic hepatitis B occurs when the immune system of an affected individual is unable to clear out the virus, leading to long-lasting infections that require lifetime antiviral treatment.
It is estimated that 240 million people worldwide live with chronic hepatitis B, resulting in approximately 1.1 million deaths every year.
Hibsago (bepirovirsen) is an antisense, oligonucleotide RNA- targeting therapy. The drug inhibits genetic components of the hepatitis B virus (HBV) to allow a reactivation of the immune system in fighting the infection. By reducing the RNA, viral proteins and amount of Hepatitis B surface antigen (HbSAg) in the blood, the drug increases the chances of a sustained, durable immune response.
The drug was granted a Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA), in addition to a Priority Review.
Approval was supported by results of the Phase 3 B-WELL trials, which yielded a 19% functional cure rate (FCR) in adults who received a six-month dose regimen. The FCR was determined by measuring levels of HBV DNA and HbSAg at 24 weeks following cessation of treatment.
Patients' eligibility for the therapy is determined by quantitative surface antigen testing. Dosing is recommended in two weekly subcutaneous injections for two weeks, followed by a single weekly dose for the remaining period of the 24-week regimen.
Ionis licensed bepiroversen to GSK by signing a collaborative development and license agreement in 2019. The company received an upfront payment from GSK, and is eligible to receive up to 10%-12% in tiered royalties on future net sales of the drug.
According to pricing determined by a previous approval in Japan, the drug costs $1,159 per 150 mL syringe.
As Hibsago is the first approved drug for hepatitis B, there are no available medications comparable at this time.
Stock Quote: IONS has been trading in a range of $38.31 ?to $86.74 in the last 1 year. The stock closed yesterday's trading at $28.19, down 9.06%.
GSK closed Tuesday down 0.60% at $51.23. The stock has traded between $45.81 and $61.70 in the past year.
5. Lucamzi (ranimizumab-blrz)
Developed by: Xbrane Biopharma AB (publ) (XBRANE.ST) and STADA
Approved on: October 27, 2026
Indication: Wet Age-Related Macular Degeneration (AMD), other retinal vascular diseases
Retinal vascular diseases constitute eye disorders wherein new blood vessels grow under the retina, leading to leakage of blood and fluid in the cornea. Disorders like neovascular (wet) Age-Related macular degeneration (AMD), diabetic macular edema (DME) and retinal vein occlusion may lead to vision loss or blindness if untreated.
Lucamzi is a biosimilar to Lucentis, a humanized monoclonal antibody fragment that received FDA approval in June 2006 and is manufactured by Novartis for the treatment of wet AMD, DME, diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV). Lucamzi is an inhibitor of the vascular endothelial growth factor (VEGF), a class of drugs that comprise a global market worth €9 billion annually.
Ranibizumab-blrz was developed by Xbrane and Swedish company STADA. The drug has been available in the European Union for the treatment of AMD in 2023, and is currently sold there under the market name Ximluci. Positive data reported in a Phase 3 trial that tested over 580 candidates with wet AMD facilitated approval.
While an FDA biologics license application (BLA) for the composition was first submitted in April 2023, approval was delayed as the agency issued two complete response letters (CRLs) in April 2024 and October 2025, respectively, raising concerns with the chosen manufacturing facility. Following thorough site inspections and required updates, Xbrane re-submitted the final BLA in April 2026.
The company stated plans to launch the drug by 2027 alongside commercialization partner Valorum Biologics, though no exact WAC has been announced till date.
Competitors:
Drug | Developer | Indication | |
|---|---|---|---|
Lucentis (ranibizumab) | Novartis AG (NVS) | Wet Age-Related macular degeneration, Diabetic macular edema, Diabetic retinopathy, and Myopic choroidal neovascularization | |
Cimerli (ranibizumab-eqrn) | Sandoz Group AG (SDZNY) | Diabetic macular edema, Diabetic retinopathy, and Age-Related macular degeneration |
Stock Quote: XBRANE.ST has been trading in the range of SEK 5.42 to SEK 20 for the past 52 weeks. Shares last closed at $12.45, up 1.63%.
6. Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd)
Developed by: Inovio Pharmaceuticals Inc. (INO)
Approved on: October 30, 2026
Indication: Reduction in surgical papilloma excisions
Recurrent respiratory papillomatosis (RRP) is a rare disease caused by the human papilloma virus (HPV), particularly the HPV-6 and HPV-11 types. The disease is characterized by the development of benign, epithelial growths along the respiratory tract, which can obstruct the airway and lead to other complications. While surgical excision of the tumors is the primary course of treatment, it is often ineffective as the papillomas grow back.
VOCERYQ is a plasmid DNA-based immunotherapy that targets the root cause of RRP by using DNA plasmids encoding HPV-6 and HPV-11 antigens. The therapy aims to reduce the frequency of papilloma excision in RRP patients through a 9-week dosage period.
The drug received Breakthrough Therapy and Orphan Drug designations from the FDA, in addition to an Orphan Drug status from the European Medicines Agency (EMA).
The drug was granted an accelerated approval, supported by results from the RRP-001 study. The trial tested the drug on 32 RRP patients who had undergone two or more surgeries previously for papilloma excision. At least 7 patients reported not requiring surgery in a 12-month follow-up period.
The company is also expected to carry out a confirmatory study for the clinical benefit of VOCERYQ, with FDA alignment on a final trial protocol anticipated by mid-2027.
VOCERYQ is administered via an electroporation technique using the CELLECTRA delivery device every 3 weeks for a total of 4 doses. Inovio has reportedly set the price of each VOCERYQ dose at $115,000, bringing the cost of the total course to $460,000.
Competitors:
Drug | Developer | Indication | |
|---|---|---|---|
Papzimeos (zopapogene imadenovec-drba) | Precigen Inc. (PGEN) | Recurrent respiratory papillomatosis |
Stock Quote: INO has been trading between $0.56 to $2.72 per share in the last year. The stock last closed up 3.97% at $1.45 per share.
For further reading, check out these drugs that received FDA approval for an expanded indication in October:
Pfizer gained approval for Talzzena-Xtandi in prostate cancer and TUKYSA in breast cancer, Eli Lilly's Jaypirca in leukemia and lymphoma, and Roche's Tecentriq in Stage 3 colon cancer. Additionally, Astrazeneca's Ultomiris received an expanded approval for proteinuria in IgA nephropathy, Novartis' Rhapsido for symptomatic dermographism, Viatris' RYZUMVI in presbyopia. Lupin's generic Vitamin K injection and the subcutaneous administration of AbbVie's SKYRIZI in treating Crohn's disease were green lit as well.
Did you know?
In October 1805, the very first United States Pharmacopeia (USP) was published. The document was entitled 'The Pharmacopeia of the Massachusetts Medical Society', and contained a comprehensive list of all drugs available at the time in the country to treat various ailments. The 286-page compendium acted as a precursor to the present-day volumes published by the American Society of Health-System Pharmacists, United States Pharmacopeial Convention, and the National Comprehensive Cancer Network (NCCN).
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