FDA approvals: Lytenava, Jideytro and OTC pain combo lead the week (2026)

At a glance

This week's verified FDA record is led by two novel drugs: Lytenava (bevacizumab-vikg) for wet age-related macular degeneration and Jideytro (zidesamtinib) for previously treated ROS1-positive non-small cell lung cancer. FDA also approved the first nonprescription tablet combining acetaminophen with naproxen sodium, posted a July 22 FluMist approval letter, and recorded the ADAMII CD34 System as a 510(k) decision. 1 2 3

The device files add 15 releasable De Novo or 510(k) decisions dated July 17 and four PMA supplement or 30-day-notice decisions dated July 17. The latest FDA download files are date-based, not time-stamped; they show no additional 510(k) or PMA records dated July 18-24 in the captured window. This makes the device section a process ledger rather than a list of new clinical indications. 4 5

The coverage window is July 17, 2026 at 5:00 p.m. through July 24, 2026 at 5:00 p.m. (UTC-05:00). Actions already covered in the July 17 issue are excluded.

Novel drugs

Lytenava: an ophthalmic bevacizumab entry in wet AMD

FDA's 2026 novel-drug list records approval on July 24 for Lytenava (bevacizumab-vikg) to treat patients with neovascular, or wet, age-related macular degeneration. The list is a concise public summary; FDA says the formal indication, population and dosing should be checked against the current prescribing information in Drugs@FDA. 1

Outlook Therapeutics said Lytenava is the first and only FDA-approved ophthalmic formulation of bevacizumab for wet AMD in the United States. The company also described the U.S. anti-VEGF retina market as approximately $8.5 billion annually and said it expects 12 years of Reference Product Exclusivity under the BPCIA. Those are company statements, not FDA market or exclusivity determinations. 6

What changed: a bevacizumab product specifically formulated for ophthalmic use has entered the FDA-approved treatment set for wet AMD. Commercial read: the addressable opportunity is large enough that retina adoption, payer treatment and the practical distinction between this formulation and established anti-VEGF options will matter more than the approval headline alone. The sources reviewed for this issue do not provide a launch price, reimbursement terms, peak-sales forecast from an independent analyst or share-price reaction.

Jideytro: a post-TKI ROS1 option with activity across treatment history

On July 22, FDA approved Jideytro (zidesamtinib), from Nuvalent, for adults with locally advanced or metastatic ROS1-positive NSCLC after at least one prior ROS1 tyrosine kinase inhibitor. The approval was supported by ARROS-1, a multicenter, open-label, single-arm, multi-cohort trial. 2

The efficacy population included 117 patients: 59 after one prior ROS1 TKI and 58 after two or more, including patients previously treated with lorlatinib, repotrectinib and/or taletrectinib. Confirmed overall response rate was 44% overall (95% CI, 34%-53%); 82% of responders had a response lasting at least six months and 69% had a response lasting at least 12 months. ORR was 49% after one prior TKI and 38% after two or more prior TKIs. 2

What changed: clinicians gained an FDA-approved option for ROS1-positive disease after prior ROS1-TKI treatment, including a population with multiple previous targeted therapies. Clinical read: the response data are relevant to sequencing, but the trial was single-arm and the label carries warnings for central nervous system adverse reactions, QTc prolongation, interstitial lung disease/pneumonitis, skeletal fractures, myalgia with creatine phosphokinase elevation, pancreatic toxicity and embryo-fetal toxicity. The recommended dose is 100 mg orally once daily until progression or unacceptable toxicity. 2

FDA says it used the Real-Time Oncology Review pilot and an Assessment Aid, approved the application two months ahead of its goal date, and granted orphan-drug designation. Commercial read: those review and designation signals may support a rapid launch in a defined molecularly selected population, but this issue's evidence does not include a price, peak-sales estimate, analyst revision or market reaction. 2

Other human-drug and biologics actions

Tylenol with Naproxen: first acetaminophen/naproxen fixed-dose OTC combination

On July 24, FDA approved Tylenol with Naproxen, made by Kenvue Brands LLC. Each tablet contains acetaminophen 325 mg and naproxen sodium 110 mg. FDA describes it as the first fixed-dose combination to pair acetaminophen with naproxen sodium in one tablet, providing up to 12 hours of pain relief. It is indicated for temporary relief of minor aches and pains in adults and children 12 years and older, including headache, backache, muscular aches, toothache, menstrual cramps and minor arthritis pain. 3

What changed: consumers have a new OTC combination option dosed every 12 hours, rather than a new prescription analgesic class. Commercial read: the opportunity is distribution, brand recognition and convenience in a large OTC pain category; the evidence reviewed here does not establish an expected price premium, incremental category share or reimbursement impact. The label warns against combining it with other acetaminophen products because of liver-damage risk and carries NSAID warnings for stomach bleeding and increased risk of heart attack, heart failure and stroke. It also says not to use naproxen sodium at 20 weeks or later in pregnancy unless directed by a doctor. 3

FluMist: approval letter posted, label detail not recoverable in this capture

FDA's weekly biologics update lists a July 22, 2026 FluMist approval letter, posted July 23. The current capture confirms the posting and the letter title but did not expose the letter's sponsor, application number, indication change or other label detail. 7 8

What changed: there is a new FDA biologics approval-letter posting in the weekly record, but not enough accessible evidence here to characterize the regulatory change. Commercial read: no responsible launch, patient-population or competitive conclusion can be drawn until the letter and corresponding label are readable.

ADAMII CD34 System: a CBER-listed 510(k) decision

FDA lists BK261351 for the ADAMII CD34 System with a July 20 decision date and NanoEntek, Inc. as applicant. FDA describes the ADAMII-CD34 Kit as designed for use with the ADAMII instrument, a benchtop image-based fluorescence cell counter. 9

What changed: the device received a 510(k) decision in a CBER-listed record, separate from the ordinary CDRH monthly K-number export below. Commercial read: the clearance supports marketing of the specified kit/instrument combination, but the evidence captured for this issue does not provide performance endpoints, pricing, reimbursement or adoption forecasts. The FDA page links to the supporting decision letter and summary for the item-level intended use and equivalence details. 9

Device decision ledger

The following is the complete set of records dated July 17 in the latest FDA 510(k) downloadable file available for this run: one De Novo decision and 14 510(k) decisions. The export includes the number, applicant, device name, product code and submission type, but not the full intended-use narrative from each decision summary. Product names below are therefore not presented as substitutes for intended use. 4

FDA number	Applicant	Device	Product code	Pathway
DEN250040	Stryker Endoscopy	SportSuite Vision Software	DENG	De Novo, Direct
K251952	Virasoft Corporation	Virasight	PSY	Traditional 510(k)
K253011	Medtronic Sofamor Danek USA, Inc.	Catalyft PL Expandable Interbody System	MAX	Traditional 510(k)
K253694	Natural Cycles Nordic AB	Natural Cycles	PYT	Traditional 510(k)
K253963	Cubresa, Inc.	Cubresa BrainPET	OUO	Traditional 510(k)
K254006	Rapid Medical Ltd.	Drivewire 35 Guidewire	MOF	Traditional 510(k)
K260694	Carl Zeiss Meditec AG	ZEISS CLINIC 360	NFJ	Traditional 510(k)
K261046	Hunan Qinghao Puzhong Technology Co., Ltd.	Dental Zirconia Blank & Coloring Liquid	EIH	Traditional 510(k)
K261475	BioFire Defense, LLC	BIOFIRE FILMARRAY Tropical Fever Panel Control Kit	PMN	Traditional 510(k)
K261614	LG Electronics Inc.	LED LCD Monitor (OEV-271H)	GCJ	Traditional 510(k)
K261658	Wellspect AB	LoFric Origo Pro Coude	EZD	Special 510(k)
K261675	Shenzhen Chuanghong Zhilian Technology Co., Ltd.	CHZL Red Light Therapy Hair Growth Cap	OAP	Traditional 510(k)
K261693	Beijing Nubway S&T Co., Ltd.	Diode laser hair removal machine (QDTM-04)	GEX	Traditional 510(k)
K261984	Assure Tech., LLC	AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup	NFT	Traditional 510(k)
K262061	Stryker Spine	Tritanium C, Tritanium PL, Tritanium TL and related interbody, cage and spacer systems	ODP	Special 510(k)

Commercial read: this list is broad rather than concentrated. It includes surgical software, an imaging system, reproductive-health software, a neuroimaging platform, a guidewire, orthopedic implants, diagnostic controls, a urinary catheter, aesthetic devices and monitoring hardware. A 510(k) or De Novo record establishes a regulatory pathway decision, not a forecast of sales, reimbursement or clinical adoption. Item-level intended-use and predicate details should be taken from each FDA decision summary before making an investment or practice decision.

PMA supplement and 30-day-notice ledger

Four PMA records dated July 17 were in the FDA downloadable PMA file. None is a new PMA for a new indication in this capture: two are Edwards manufacturing-site changes and two are Abbott process-change notices. 5

PMA supplement	Sponsor	Device	Decision track	Change recorded
P140031 S192	Edwards Lifesciences, LLC	Edwards Crimper 9600CR	APPR; normal 180-day track	Location change involving manufacturer/sterilizer/packager/supplier
P200015 S069	Edwards Lifesciences, LLC	Edwards SAPIEN 3 Pulmonic Delivery System 9630PL29	APPR; normal 180-day track	Location change involving manufacturer/sterilizer/packager/supplier
P140009 S134	Abbott Medical	Deep Brain Stimulation Implantable Pulse Generator	OK30; 30-day notice	Process change involving manufacturer/sterilizer/packager/supplier
P010032 S255	Abbott Medical	Spinal Cord Stimulation Implantable Pulse Generator	OK30; 30-day notice	Process change involving manufacturer/sterilizer/packager/supplier

Commercial read: these actions are primarily supply-chain and manufacturing continuity events. They can matter for capacity, quality-system execution and product availability, but they should not be counted as new clinical indications or as evidence of incremental patient demand.

What matters next

Lytenava: launch timing, payer treatment and real-world retina adoption will determine whether the ophthalmic formulation converts the company's stated market opportunity into share.
Jideytro: the full Drugs@FDA label, launch terms and post-TKI sequencing data will refine its position against other ROS1-directed therapies.
Tylenol with Naproxen: retail availability, consumer uptake and safety communication will be more informative than the approval itself for Kenvue's commercial outcome.
Devices: the next useful diligence step is item-level review of the 510(k) and De Novo summaries, because the monthly export does not include intended-use narratives or clinical performance detail.
FluMist: the approval letter and updated label remain necessary before assessing the action's patient or market impact.

FDA approvals: Lytenava, Jideytro and OTC pain combo lead the week