FDA approvals: Pasatru, Genglycos and the Aletta blood-draw robot lead the Aug. 14–21 ledger
This week's verified FDA record is led by Pasatru for FOP, Genglycos for GSDIa, an autoinjector and kidney-label update, and the Aletta robotic blood-draw authorization, with device-ledger limits kept explicit.
The Aug. 14–21, 2026 window produced two new therapies, three clinically meaningful label or delivery actions, and a small set of device records that can be verified directly. The drug record is led by Pasatru for fibrodysplasia ossificans progressiva (FOP) and Genglycos for glycogen storage disease type Ia (GSDIa). The device record is led by Aletta, an adjacent De Novo authorization for a robotic blood-draw device.
At a glance
This issue covers actions recorded from Aug. 14 at 17:00 through Aug. 21 at 17:00, UTC-05:00. FDA detail pages generally expose calendar dates rather than intraday timestamps, so Aug. 14 entries are date-bounded records within the scheduled window. Drugs@FDA also warns that late database additions can appear after the report period and directs readers to its monthly report for a comprehensive approval report. 1
| Action | FDA record date | Sponsor or applicant | What changed |
|---|---|---|---|
| Pasatru (garetosmab-grts) | Aug. 19 | Regeneron Pharmaceuticals | New treatment to reduce heterotopic ossification and clinician-assessed flares in adults with FOP. 2 |
| Genglycos (pariglasgene brecaparvovec-opnr) | Aug. 19 | Ultragenyx Pharmaceutical | Accelerated approval for adults and children age 8 and older with GSDIa to reduce daily cornstarch intake as an adjunct to nutritional management. 3 |
| Lerochol (lerodalcibep-liga), BLA 761427 | Aug. 18 in Drugs@FDA; letter signed Aug. 13 | LIB Therapeutics | Supplement adding a single-dose autoinjector; the company also describes updated indication wording. 4 |
| Yesintek (ustekinumab-kfce), BLA 761406 | Aug. 14 | Biocon Biologics | Supplement adding single-dose prefilled autoinjector presentations across the existing ustekinumab label. 5 |
| Empaveli (pegcetacoplan), NDA 215014 | Aug. 20 | Apellis Pharmaceuticals | Label update for C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis, plus aligned REMS materials. 6 |
| Aletta | Aug. 19 | Vitestro | Adjacent De Novo authorization for an adult outpatient robotic blood-draw device; this is separate from the 510(k)/PMA ledger. 7 |
| Redermax Antibacterial Wound Matrix, K261646 | Aug. 14 | Beijing Kreate Medical | Traditional 510(k) decision of Substantially Equivalent; The FDA detail page lists no full intended-use narrative. 8 |
| Disposable Pen Injector, K253747 | Aug. 14 | Jiangsu Enjosim Medical Technology | Traditional 510(k) decision of Substantially Equivalent; The FDA detail page lists no full intended-use narrative. 9 |
The public CDRH return lacks a complete Aug. 14–21 510(k) or PMA ledger. The 510(k) landing page was last updated Aug. 17 and exposes the database definition and search entry point rather than a complete current-week decision list. 10 The device section below therefore records the FDA decisions that were directly verified and keeps the coverage boundary visible.
New drugs and biologics
Pasatru: a second approved FOP treatment
The FDA lists Pasatru (garetosmab-grts) as a novel-drug approval dated Aug. 19. The agency approved it for adults with FOP to reduce new heterotopic ossification, meaning bone formation outside the skeleton, and clinician-assessed disease flare-ups. Regeneron Pharmaceuticals is the sponsor. 11
FOP is caused by a mutation in activin A receptor-type 1, a receptor involved in new bone growth. Pasatru is an antibody that blocks activation of the abnormal receptor. The recommended starting dose is 10 mg/kg by intravenous infusion over 60 minutes every four weeks. The dose may fall to 3 mg/kg every four weeks when the starting dose is not tolerated. 2
The pivotal randomized, double-blind, placebo-controlled study enrolled 63 adults and followed them for 56 weeks. The 10 mg/kg group had two new heterotopic-ossification lesions among 23 patients; the 3 mg/kg group had one lesion among 19 patients; the placebo group had 19 lesions among 21 patients. Clinician-assessed flares totaled nine in the 10 mg/kg group, 53 in the 3 mg/kg group, and 66 with placebo. 2
The label warns about fetal harm, serious skin and soft-tissue infections, and nosebleeds that require medical intervention. Pasatru received Breakthrough Therapy, Fast Track, Orphan Drug, and Priority Review designations. 2
Commercial read. The FDA describes Pasatru as the second approved FOP treatment. Regeneron estimates that about 900 people worldwide have been diagnosed with FOP, and the company says some patients may be appropriate for home infusion. Regeneron also says it plans to start an adolescent and pediatric Phase 3 OPTIMA 2 trial later in 2026. The 900-patient figure and the home-infusion and development plans are company-reported. 12
The commercial question is therefore concentrated in diagnosis, infusion capacity, and real-world control of new bone formation and flares. Regeneron's announcement gives no list price, and the public sources used for this issue provide no verified approval-specific REGN price move, analyst revision, or institutional note.
Genglycos: the first approved therapy for GSDIa
The FDA granted accelerated approval to Genglycos (pariglasgene brecaparvovec-opnr) on Aug. 19 for adults and children age 8 and older with GSDIa. The product reduces daily cornstarch intake as an adjunct to nutritional management. Ultragenyx Pharmaceutical is the sponsor, and the FDA calls Genglycos the first approved treatment for GSDIa. 3
GSDIa results from a missing glucose-6-phosphatase enzyme, which limits the body's ability to release glucose from stored liver glycogen. Genglycos is a one-time AAV8 gene therapy designed to deliver a functional G6PC gene to the liver. Daily, around-the-clock cornstarch supplementation remains part of the nutritional-management context for the approved use. 3
The accelerated approval rests on a surrogate endpoint: reduced daily cornstarch intake. In a randomized, double-blind, placebo-controlled study followed for 48 weeks, Genglycos produced a statistically significant mean 31% reduction from baseline in daily cornstarch intake versus placebo. The secondary endpoint showed a mean reduction of one cornstarch dose per day. Genglycos-treated patients had a numerical mean 3% increase in glucose values below 70 mg/dL versus placebo. Ultragenyx must complete additional trials to confirm clinical effectiveness. 3
Serious adverse reactions included anaphylaxis, adrenal insufficiency, high lactate levels, and hypoglycemia. The prescribing information warns about anaphylaxis, liver toxicity, adrenal insufficiency, tumorigenicity, and pregnancy use. 3
Commercial read. Reuters reports that the company estimates 1,500 to 2,500 GSDIa patients in the United States. The company told Reuters that Genglycos will carry a $2.7 million per-patient U.S. list price and should be available through qualified treatment centers within 30 to 60 days. Reuters also reports that early-stage GSDIa programs from Moderna and Beam Therapeutics are in development. 13
The approval creates a first product in a condition managed mainly with strict dietary supplementation. The near-term diligence questions are payer treatment of a multimillion-dollar one-time therapy, treatment-center capacity, confirmatory evidence, and the durability of glucose control. Reuters reported that Ultragenyx shares rose 7.5% in after-hours trading after the announcement. The Reuters report supplies an approval-specific market reaction for Ultragenyx; comparable public evidence was not verified for the other sponsors in this issue. 13
Label and administration actions
These actions change how established products are delivered or described in the label. They carry clinical and commercial consequences, but they should be read separately from a new molecular approval.
Lerochol: autoinjector approval with a date discrepancy
Drugs@FDA records the Lerochol (lerodalcibep-liga) action under BLA 761427, SUPPL-1, with an Aug. 18 action date. The FDA approval letter says the supplement introduces a single-dose autoinjector presentation and makes the approval effective on the date of the letter. The letter carries an electronic signature dated Aug. 13; LIB Therapeutics announced the action on Aug. 17. 41415
The letter also includes instructions for use for the single-dose autoinjector alongside the existing single-dose prefilled syringe. LIB says the autoinjector is expected to be available in January 2027 and that the direct-to-patient cash price will remain $199 per month. LIB also reports up to 90 days of room-temperature storage and once-monthly self-administration. Those launch and price details are company-reported. 1415
LIB says the FDA also updated the indication wording to describe reduced major adverse cardiovascular-event risk associated with LDL-C lowering when Lerochol is used with statins or monoclonal-antibody PCSK9 inhibitors as an add-on to statin therapy. LIB cites Phase 3 LIBerate enrollment of more than 2,900 patients and sustained LDL-C reductions of at least 60% in high-risk or cardiovascular-disease populations and at least 59% in heterozygous familial hypercholesterolemia. These efficacy figures come from the company announcement. 15
Commercial read. The autoinjector gives LIB a delivery-format lever in a chronic LDL-C-lowering market that already includes an existing syringe and established PCSK9 therapies. The January 2027 availability date, the $199 company-reported cash price, and insurer handling of the revised indication will matter more for uptake than the supplement's regulatory label alone. No approval-specific analyst revision or independent share-price reaction was verified for LIB in the sources used here.
Yesintek: a biosimilar delivery-format expansion
FDA records show an Aug. 14 action for Yesintek (ustekinumab-kfce), BLA 761406, SUPPL-2. The FDA classification is "Efficacy-Manufacturing Change With Clinical Data." The current label lists single-dose prefilled autoinjectors in 45 mg/0.5 mL and 90 mg/mL strengths alongside the existing syringe and vial presentations. Biocon Biologics announced the approval on Aug. 18. 516
Yesintek is a biosimilar to Stelara (ustekinumab). Its existing label covers moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults and children age 6 and older, plus moderately-to-severely active Crohn's disease and ulcerative colitis in adults. The label warns about serious infections, tuberculosis, malignancy, serious hypersensitivity, posterior reversible encephalopathy syndrome, live vaccines, and noninfectious pneumonia. 17
Commercial read. The regulatory change adds a self-injection format across a broad existing label. The practical contest is convenience, training, and access across home and clinical settings, while the reference product supplies an established treatment benchmark. Biocon's announcement contains no price, market-share, or launch-revenue guidance, and no approval-specific public-market reaction was verified for Biocon.
Empaveli: kidney-function language and REMS alignment
FDA records show an Aug. 20 approval for Empaveli (pegcetacoplan), NDA 215014, SUPPL-12, classified as an efficacy-labeling change with clinical data. The supplement updates the indication for adults and children age 12 and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) to reduce proteinuria and loss of kidney function. 618
The FDA letter also approves a modified Empaveli REMS. The changes update the healthcare-provider safety brochure, patient guide, and REMS website so they match the revised indication; the REMS assessment timetable remains the same. 18
Commercial read. Apellis reported in January that it estimated a U.S. population of about 5,000 people with C3G and primary IC-MPGN, more than 5% penetration based on cumulative patient-start forms, 95% of policies covering to label or with minimal restrictions, and approximately $102 million in 2025 U.S. Empaveli net product revenue. These are company-reported commercial measures, not independent market forecasts. 19
The revised kidney-function language gives clinicians and payers a more direct label endpoint to evaluate. The next access question is whether the updated REMS materials and the broader benefit statement change prescribing and reimbursement behavior in a small, specialist-treated population. No approval-specific analyst or institutional commentary was verified.
Other captured Drugs@FDA actions
The Drugs@FDA report also contains named NDA and BLA rows within the window. The report mixes new, supplemental, labeling, efficacy, manufacturing, REMS, and generic actions, and it warns that late database additions can occur. The rows below remain a ledger of captured records rather than a claim that each represents a new molecular approval. 1
| FDA date | Named records in the captured report | Reading of the record |
|---|---|---|
| Aug. 14 | Alecensa; Jascayd; Suboxone | Named NDA/BLA rows, with label or other action details requiring separate product-level review. 1 |
| Aug. 17 | Zavzpret | Named NDA row in the report; the captured row does not provide enough information here for a full clinical-commercial profile. 1 |
| Aug. 18 | Baraclude; Tyzavan | Named NDA rows classified in the report as labeling actions. 1 |
| Aug. 19 | Leqvio | Named NDA row classified in the report as a labeling action. 1 |
| Aug. 20 | Cotellic; Ogsiveo; Takhzyro; Yesafili; Zelboraf | Named NDA/BLA rows classified in the report as labeling actions. 1 |
Tauklarify is excluded from this issue because the FDA novel-drug table gives it an Aug. 13 approval date, before the current window. 11
Medical devices
The verified 510(k) records
A 510(k) clearance is a finding that a device is substantially equivalent to a legally marketed device that is not subject to premarket approval. The two directly verified in-window records are both dated Aug. 14 and both carry the FDA decision “Substantially Equivalent (SESE).” 10
| 510(k) | Device | Applicant | Classification and decision | Intended-use detail |
|---|---|---|---|---|
| K261646 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | Dressing, Wound, Drug; product code FRO; General & Plastic Surgery; Traditional 510(k); SESE on Aug. 14. 8 | The fetched FDA detail page does not provide a full intended-use narrative. |
| K253747 | Disposable Pen Injector, KXYC-03C02 and KXYC-03A03 | Jiangsu Enjosim Medical Technology Co., Ltd. | Syringe, Piston; product code FMF; General Hospital; Traditional 510(k); SESE on Aug. 14. 9 | The fetched FDA detail page does not provide a full intended-use narrative. |
The device names and product codes do not establish how either product is used clinically. Their commercial significance therefore remains unresolved until the underlying 510(k) summaries or intended-use details are available. No verified pricing, reimbursement, market-size, or adoption signal accompanied these records.
Adjacent CDRH De Novo action: Aletta
The FDA authorized Aletta on Aug. 19 through the De Novo pathway, which is used for low- to moderate-risk devices of a new type. Vitestro is the manufacturer. The authorization covers adults in outpatient settings under the oversight of a supervisor trained in phlebotomy. One phlebotomist can oversee up to three Aletta devices. 7
Aletta uses near-infrared light and Doppler ultrasound to locate a suitable vein and distinguish veins from arteries. It handles the tourniquet, skin preparation, needle insertion and disposal, collection-tube changes, and bandaging. The procedure stops when the device finds no suitable vein or detects unsafe movement. A trained phlebotomist starts each session, checks tube order and fill, and remains available throughout. 7
FDA says clinical data showed successful blood-draw rates comparable to or better than trained phlebotomists when the device proceeded with a stick, across patients with different health statuses, self-reported difficult vein access, and varying skin tones. Device-related adverse events were uncommon and mild. The De Novo authorization establishes special controls covering labeling, performance testing, and clinical testing. 7
Commercial read. Aletta has a clearer operational proposition than the two 510(k) records because the FDA describes its intended setting, staffing model, safety stops, and clinical evidence. The immediate adoption questions are capital cost, throughput, training, infection-control workflow, and whether outpatient operators can use one supervisor across three devices without adding delays. The FDA authorization leaves pricing and reimbursement terms open, and no approval-specific investor reaction was verified.
What matters next
- Pasatru: watch the first launch evidence on monthly infusion delivery, home-infusion eligibility, flare control, and new heterotopic-ossification outcomes. Regeneron's planned adolescent and pediatric OPTIMA 2 program is the next expansion signal. 12
- Genglycos: follow confirmatory-trial execution, the required two-year safety and efficacy evidence reported by Reuters, qualified treatment-center rollout, and payer treatment of the $2.7 million company-reported list price. 13
- Lerochol and Yesintek: track autoinjector availability, patient training, room-temperature handling, persistence, and whether the new formats improve access in routine care. 1516
- Empaveli: monitor REMS implementation, payer interpretation of the loss-of-kidney-function language, and whether the revised label changes use in C3G and primary IC-MPGN. 18
- Devices: recheck the FDA 510(k) and PMA databases after their next refresh. The current public return identifies two Aug. 14 510(k) decisions and the Aug. 19 Aletta De Novo authorization, while the available device ledger remains incomplete. 1020
- Markets: Reuters provides a documented 7.5% after-hours move for Ultragenyx after Genglycos. No comparable approval-specific analyst revision, institutional commentary, or public-market reaction was verified for the other named sponsors and applicants in this issue. 13
References
- 1Recent New and Generic Drug Approvals
accessdata.fda.gov
- 2
- 3
- 4Lerochol Drugs@FDA application record
accessdata.fda.gov
- 5Yesintek Drugs@FDA application record
accessdata.fda.gov
- 6Empaveli Drugs@FDA application record
accessdata.fda.gov
- 7
- 8510(k) K261646: Redermax Antibacterial Wound Matrix
accessdata.fda.gov
- 9510(k) K253747: Disposable Pen Injector
accessdata.fda.gov
- 10510(k) Premarket Notification
accessdata.fda.gov
- 11
- 12Pasatru (garetosmab-grts): First and Only FDA-Approved Treatment for FOP
investor.regeneron.com
- 13
- 14Lerochol BLA 761427/S-001 supplement approval letter
accessdata.fda.gov
- 15
- 16
- 17Yesintek prescribing information
accessdata.fda.gov
- 18Empaveli NDA 215014/S-012 supplement approval letter
accessdata.fda.gov
- 19Apellis highlights commercial execution and strategic priorities
investors.apellis.com
- 20CDRH New - News and Updates
fda.gov
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