NEW YORK CITY (dpa-AFX) - The U.S. Food and Drug Administration (FDA) granted approval to 13 drugs last month, comprising both new drug approvals and expanded indications for previously approved therapies.
Let's take a closer look at these newly approved drugs, their indications, and key pricing information.
mFLUSIVA (mRNA-1010)
Developed by: Moderna Inc. (MRNA)
Approved on: August 5, 2026
Indication: Prevention of Influenza A and influenza B in patients of 50 years or older
Formerly known as mRNA-1010, mFLUSIVA is recommended for administration once a year during the flu season.
The drug is delivered through an intramuscular injection in the upper arm at doses of 0.38 mL or more. The vaccine is also recommended for adults 65 years or older on an accelerated approval basis.
Earlier this year, the company published positive data from a pivotal Phase 3 study demonstrating the drug's relative vaccine efficiency (rVE) compared to existing vaccines. The rVE was reported at 26.6%, and the vaccine was also found to have a consistent safety profile.
A study on patients aged 65 years or older showed viable results for hemagglutination inhibition (HAI), geometric mean titer (GI), and seroconversion rates. Serious adverse events were reported only in 2.7% of patients in the mFLUSIVA test group, six months after dosage.
mFLUSIVA may now be provided at a list price or wholesale acquisition cost (WAC) of $149.56 per dose.
Competitors: Sanofi's Fluzone, Fluzone High-Dose; Seqirus' Fluad; and GSK's Fluarix, to name a few.
Orzeyful
Developed by: Takeda Pharmaceuticals (TAK)
Approved on: August 5, 2026
Indication: Narcolepsy type 1 in adults
Narcolepsy is a disorder which causes extreme lethargy during the day, as the patient may fall asleep suddenly in the middle of an activity. The type 1 form of narcolepsy may be accompanied by the sudden loss of muscle tone, known as cataplexy, prior to falling asleep.
Orezyful, whose active ingredient is oveporexton, works as an oveporexton receptor 2 (OXR2) agonist, and restores orexin mobility. The drug selectively stimulates the OX2R to restore signaling and address the underlying orexin deficiency that causes narcolepsy type 1 (NT1).
The drug promotes wakefulness, reduces abnormal repeated eye movement (REM) sleep phenomena and decreases cataplexy.
Takeda conducted the Phase 3 global, multicenter, placebo-controlled FirstLight and RadiantLight studies with 168 and 105 patients respectively. Of those enrolled, more than 95% patients volunteered to continue in the ongoing long-term extension (LTE) study.
The released data indicates that patients on various doses of oveporexton showed significant improvements in daily functioning by week 12. This was measured in six domains of the Functional Impacts of Narcolepsy Instrument (FINI), which evaluates tiredness, cognitive functioning, cataplexy, social activities, everyday activities and everyday responsibilities.
Patients also showed improved cognitive symptoms, as measured on the FINI Cognitive Function domains. Over 70% of patients reported no cognitive difficulties after dosing, compared to only 15% in the placebo arm. Furthermore, dosed patients saw an improvement in the quality of nighttime sleep, and reduced disturbances in sleep from the baseline.
While FDA-approved, the drug is still categorized as a controlled substance by the U.S. Drug Enforcement Agency (DEA), and is not yet available for use. There is thus no WAC provided by the company at this time.
Competitors: Harmony Biosciences' Wakix; Jazz Pharma's Xyway and Xyrem; Avadel Pharma's Lumryz; and Axsome Therapeutics' Sunosi.
Tudriqev (vusolimogene oderparepvec-wtpg)
Developed by: Replimune Inc. (REPL)
Approved on: August 6, 2026
Indication: Unresectable advanced melanoma of the skin in adults
Tudriqev, or vusolimogene oderparepvec-wtpg, is a genetically modified oncolytic therapy consisting of an attenuated Herpes simplex virus type 1 (HSV-1). The virus enters the tumor and lyses cancer cells to alert the immune system toward the malignancy, while also carrying certain genes to promote tumor necrosis.
The drug works in combination with the monoclonal antibody nivolumab for patients with unresectable, advanced melanoma following treatment with an anti-PD-1 inhibitor. Supported by positive results from the Phase 3 IGNYTE-3 trial, the approval was granted on the third re-submission of the company's biologics license application (BLA) for the drug.
Advanced melanoma remains a difficult-to-treat cancer, with no alternatives offered to patients with disease progression despite anti-PD-1 therapy. Over 8,500 people die from melanoma every year in the U.S. alone, and affected individuals face a lifetime of co-morbidities and poor survival outcomes.
TUDRIQEV reportedly has a list price of $450,000 for a full course of therapy.
Competitors: Merck's Keytruda; Bristol-Myers Squibb's Opdivo and Opdualag; Amgen's Imlygic.
Zenbexus (iberdomide) Capsules
Developed by: Bristol-Myers Squibb Co (BMY)
Approved on: August 13, 2026
Indication: Multiple Myeloma
Bristol-Myers Squibb's cereblon-modulating protein degrader, Zenbexus, also known as iberdomide, was approved by the FDA in combination with daratumumab, hyaluronidasefihj and dexamethasone (ZDd) to treat adults with multiple myeloma who previously received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
Zenbexus binds to the cereblon protein, triggering the degradation of Ikaros and Aiolos, proteins involved in myeloma cell growth and survival. This leads to tumor growth inhibition and immune-mediated activity against myeloma cells.
The approval of Zenbexus was based on results from the Phase 3 EXCALIBER-RRMM study involving more than 939 subjects. The drug demonstrated a higher minimal residual disease-negative complete response rates with Zenbexus versus daratumumab, bortezomib and dexamethasone (41% vs. 21%).
Multiple myeloma is a hematologic malignancy characterized by the abnormal proliferation of plasma cells in the bone marrow. The disease primarily affects older adults. In the U.S., approximately 36,000 new cases are expected in 2026, with an age-adjusted incidence rate of 7.4 cases per 100,000 people.
According to Bristol Myers Squibb, Zenbexus has a list price of $29,500 per 28-day treatment cycle.
Competitors: Amgen's Kyprolis; Takeda'sVelcade; Johnson & Johnson's Darzalex/ Darzalex Faspro; Sanofi's Sarclisa; Bristol Myers Squibb's Revlimid, and Pfizer's Elrexfio, to a name a few.
Tauklarify (MK-6240)
Developed by: Lantheus Holdings Inc. (LNTH)
Approved On: August 14, 2026
Indication: Radiodiagnostic agent for Alzheimer's disease
Tauklarify constitutes a florquinitau F18 injection administered to patients with impaired cognition being evaluated for various neurodegenerative disorders. By identifying tau neurofibrillary tangle (NFT) pathologies, the agent can effectively quantify amyloid deposits in the brain to definitively diagnose Alzheimer's disease.
The approval was based on positive results from the Study 1 and Study 2, which evaluated PET images from 279 and 338 patients, respectively. The trials yielded a positive percent agreement (PPA) of 80% to 88% in Study 1, and between 68% and 82% in Study 2.
The agent may now be used in patients undergoing positron emission tomography (PET) scanning to identify and diagnose Alzheimer's disease. It is injected intravenously about 90 minutes before a scheduled PET scan in a dose of 185 MBq, yielding a minimal radiation of 5.4 mSv.
Lantheus also markets Neuraceq, a florbetsben F18 injection for detecting Beta amyloid deposits in the brain, characteristic of certain Alzheimer's cases.
Competitors: Eli Lilly 's Amyvid and Tauvid; and GE HealthCare's Vizamyl.
Pasatru (garetosmab-grts)
Developed by: Regeneron Pharmaceuticals Inc. (REGN)
Approved on: August 19, 2026
Indication: Fibrodysplasia ossificans progressiva (FOP)
The FDA granted approval to Pasatru (garetosmab-grts) injection to reduce the formation of new heterotopic ossification lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).
Pasatru is a VelocImmune-derived, fully human monoclonal antibody, designed to block Activin A, a protein involved in the development of heterotopic lesions in patients with FOP.
The approval was based on results from the Phase 3 OPTIMA trial, which met its primary and secondary endpoints. The recommended starting dose is 10 mg/kg administered intravenously once monthly, with the option to reduce the dose to 3 mg/kg if the higher dose is not tolerated.
Fibrodysplasia ossificans progressiva is a rare genetic disorder in which muscles, ligaments, tendons, and other connective tissues transform into bone through the formation of heterotopic lesions. The condition can impair bodily functions and lead to loss of mobility. Approximately 900 people worldwide are diagnosed with FOP, with a median survival age of 56 years.
Pasatru carries an annualized Wholesale Acquisition Cost (WAC) of approximately $1.4 million, with the company reporting a range of $693,000 to $2.1 million depending on patient weight and dose.
Competitors: Ipsen's Sohonos (palovarotene), which launched in 2023 with an annual WAC of $624,000.
Zilurgisertib, developed by Mirum Pharmaceuticals, is also being evaluated for FOP and awaits FDA approval.
Genglycos (pariglasgene brecaparvovec-opnr)
Developed by: Ultragenyx Pharmaceuticals Inc. (RARE)
Approved on: August 19, 2026
Indication: Glycogen storage disease type Ia (GSDIa)
Genglycos (pariglasgene brecaparvovec-opnr), also known as DTX401, is approved by the FDA for the treatment of adult and pediatric patients aged eight years and older with glycogen storage disease type Ia (GSDIa).
Genglycos is the first FDA-approved therapy to address the underlying cause of GSDIa, with clinical studies showing reduced cornstarch requirements and improved glucose regulation during fasting or metabolic stress. It uses a recombinant, non-replicating AAV8 vector designed for sustained glucose regulation.
The approval was based on the Phase 3 GlucoGene study, which showed a significant reduction in cornstarch requirements in the treated groups at Week 48.
Glycogen storage disease type Ia (GSDIa), also known as Von Gierke disease, is an ultra-rare genetic metabolic disorder caused by a deficiency of the enzyme needed to release glucose from the liver into the bloodstream. Patients face life-threatening hypoglycemia episodes and other complications, requiring a burdensome regimen of raw cornstarch intake around the clock as an oral glucose replacement therapy.
The condition affects an estimated 1,500-2,500 patients in the U.S. and 6,000-8,000 worldwide.
Ultragenyx has set a U.S. wholesale acquisition cost (WAC) of $2.7 million per patient for Genglycos.
Ziihera (zanidatamab-hrii)
Developed by: Zymeworks Inc. (ZYME); licensed to Jazz Pharmaceuticals (JAZZ)
Approved on: August 25, 2026
Indication: HER2+ Gastroesophageal adenocarcinoma (GEA)
Ziihera has been approved for the first-line treatment of adults with unresectable, locally advanced or metastatic HER2-positive (HER2+) GEA. The approval covers two Ziihera-containing regimens: Ziihera in combination with Tevimbra (tislelizumab-jsgr) and fluoropyrimidine- and platinum-containing chemotherapy for patients with HER2 IHC 3+ or IHC 2+/ISH+ tumors; and Ziihera in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with HER2 IHC 3+ tumors.
Esophageal cancers are fairly common, with 17,000 new cases and around 15,500 deaths recorded in the U.S. alone every year. Gastroesophageal adenocarcinomas originate from the glandular cells located in the gastroesophageal junction.
Developed by Zymeworks using its proprietary Azymetric platform, the drug was licensed to Jazz Pharmaceuticals in 2022 to facilitate assessments in combination therapies for HER2+ GEA.
Ziihera (zanidatamab-hrii) is a neoadjuvant therapy that originally received FDA approval for HER2+ cholagiocarcinoma or biliary tract cancer on November 20, 2024. The lyophilized powder is administered as an intravenous infusion every two weeks.
According to 2024 data, the Wholesale Acquisition Cost for Ziihera is $35,500 over a 28-day course.
Competitors: Roche's Herceptin; Teva/Celltrion's Herzuma; Daiichi Sankyo/AstraZeneca's Enhertu, among others.
Rasonque (daraxonrasib)
Developed by: Revolution Medicines Inc. (RVMD)
Approved on: August 26, 2026
Indication: Metastatic pancreatic adenocarcinoma (PDAC)
The FDA approved Rasonque (daraxonrasib) as a once-daily tablet for the treatment of adults with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy, or who are not candidates for multiagent systemic therapy.
Rasonque is an oral, RAS(ON) multi-selective, non-covalent, tri-complex inhibitor, designed to target cancers driven by a broad range of common RAS genotypes, including pancreatic adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and colorectal cancer.
The approval was based on the Phase 3 RASolute 302 trial, in which the drug met all primary and key secondary endpoints in both the RAS G12 mutant population and the overall intent-to-treat (ITT) population, including patients with or without an identified tumor RAS mutation.
Pancreatic cancer is among the most challenging malignancies, frequently presenting with a late diagnosis, aggressive biology and limited responsiveness to conventional treatments.
RAS, a key growth-control switch in human cells, is frequently altered in pancreatic cancer, resulting in excessive RAS signaling.
Revolution has set a Wholesale acquisition cost (WAC) of $39,800 for a 30-day supply of Rasonque.
Competitors: Ipsen's Onivyde; Bristol Myers Squibb's Abraxane; AstraZeneca's Lynparza, among others.
LISRAYA (brepocitinib)
Developed by: Roivant Sciences Ltd (ROIV)
Approved on: August 27, 2026
Indication: Dermatomyositis (DM)
Dermatomyositis (DM) is a rare autoimmune disorder that causes muscle weakness and painful, pruritic skin lesions. The disease may severely impair a patient's quality of life, causing cutaneous disfigurement and extensive sensitivity to light and touch. Affected individuals are often treated with a chronic high-dose of steroids.
LISRAYA (brepocitinib) is a first-in-class potent, small-molecule inhibitor of TYK2/JAK1 that has shown a high efficacy in DM patients by reducing the extent of skin disease, muscle weakness, and overall disease burden.
The approval was supported by results from the Phase 3 VALOR trial, which met its primary endpoint by showing improvements on the myositis Total Improvement Score by Week 4 of dosing. 55% of patients on LISRAYA showed a moderate or better improvement in the score, compared to only 30% on the placebo.
Roivant initiated the My Compass Support program, through which dermatomyositis patients may pay as little as $0 per month to receive LISRAYA treatment.
Competitor: Octapharma's Octagam 10%
Bixlenvo (bictegravir and lenacapavir) Tablets
Developed by: Gilead Pharmaceuticals Inc. (GILD)
Approved on: August 27, 2026
Indication: HIV-1 infection
Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg) is formulated as a once-daily single tablet regimen for the treatment of HIV in virologically suppressed adults. It is the first single-tablet regimen (STR) indicated for virologically suppressed adults who are unable to take currently available STRs, including those on complex HIV treatment regimens.
The drug combines bictegravir, an integrase strand transfer inhibitor (ISTI), with lenacapavir, a capsid inhibitor with a novel mechanism of action and no cross-resistance to other antiretrovirals. Together, bictegravir and lenacapavir target multiple stages of HIV life cycle.
In Phase 3 trials, dubbed ARTISTRY-1 and ARTISTRY-2, Bixlenvo showed comparable virologic suppression at Week 48, with improvements in treatment satisfaction and certain fasting lipid parameters, and was generally well tolerated.
Human Immunodeficiency Virus type 1 (HIV-1) is the most common and widespread form of HIV globally. It affects the immune system, specifically CD4 cells, leading to the weakening of the body's ability to fight. If left untreated, the infection can progress to Acquired Immunodeficiency Syndrome (AIDS).
Bixlenvo reportedly has a wholesale acquisition cost (WAC) of $4,595 for a 30-day supply.
Competitors: Gilead Sciences' Biktarvy; Merck's Idvynso; ViiV Healthcare's Dovato, Cabenuva, and Juluca, among others.
Mimrylo (rusfertide) Lyophilized Powder for Injection
Developed by: Takeda Pharmaceuticals Co Ltd. (TAK) and Protagonist Therapeutics Inc. (PTGX)
Approved on: August 28, 2026
Indication: Polycythemia Vera
Polycythemia Vera (PV) is a chronic blood cancer characterized by overproduction of red blood cells, which increased blood viscosity resulting in thrombotic events such as stroke, deep vein thrombosis and pulmonary embolism.
The disease is estimated to affect approximately 90,000 people in the U.S. The current treatment option is to maintain hematocrit levels below 45%, with hematocrit referring to the proportion of red blood cells (RBC) in the blood.
Mimrylo is a subcutaneous treatment that mimics hepcidin, a hormone regulating iron homeostasis and RBC production. The drug is designed to limit excess RBC production and maintain healthier RBC levels.
The FDA approved Mimrylo based on results from the Phase 3 VERIFY trial, which enrolled 293 patients with polycythemia vera (PV) and demonstrated improved hematocrit control, a reduced need for phlebotomy, and improvements in fatigue with treatment.
Competitors: Incyte's Jakafi; PharmaEssentia's Besremi.
COMIRNATY XFG (COVID-19 Vaccine, mRNA)
Developed by: Pfizer Inc. (PFE) and BioNTech
Approved on: August 28, 2026
Indication: COVID-19
Pfizer and BioNTech's COMIRNATY XFG received FDA approval as an updated COVID-19 vaccine targeting the XFG variant. The approval follows FDA guidance recommending XFG as the preferred strain for COVID-19 vaccine composition in the U.S. for the fall 2026 season.
The vaccine is approved for adults aged 65 years and older, as well as individuals aged 5 through 64 years with at least one underlying condition that puts them at high risk for severe COVID-19 outcomes.
The FDA approval was supported by clinical, non-clinical and real-world data demonstrating the safety and effectiveness of COMIRNATY. Manufacturing, quality and non-clinical data further showed that the XFG-adapted formulation generated strong immune responses against circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1.
Competitors: Moderna's mNEXSPIKE and Spikevax, and Novavax/Sanofi's NUVAXOVID.
Did You Know?
Last month marked 25 years since the famous Cloning Conference was held by the National Academy of Science in Washington D.C. The event brought geneticists, infertility experts and experimental researchers together to debate human cloning. It came a few years after the creation of Dolly the sheep in 1997, with the scientists behind the successful cloning wary of applying the technique to humans. Cloning in large mammals was erratic, with offspring potentially facing severe deformities or premature births. Most cloning experiments were unsuccessful, while one study found that repeated cloning across multiple generations of mice magnified genetic defects. Cloning continues to raise ethical questions, and despite advances in research, practical applications involving humans remain outlawed in most parts of the world.
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