FDA approvals: Atebrioz, Juvmo and Onswik lead the Sep. 19–25 ledger
A date-bounded review of four never-before-approved drugs — Atebrioz for fibrodysplasia ossificans progressiva, Juvmo for Parkinson's disease, Lyrfigtu for FGFR2-altered bile duct cancer, and Onswik, the second weekly insulin — plus Gazyva's first-in-class nephrotic syndrome indication, a new second-line kidney cancer regimen, and the captured FDA device ledger for September 19–25, 2026.
The FDA cleared four drugs it had never approved before in the seven days from September 19 through September 25, 2026: a pill for the disease that turns muscle into bone, a new oral Parkinson's medicine, a selective FGFR2 inhibitor for bile duct cancer, and the second weekly insulin. The same window produced the first approved way to keep childhood-onset nephrotic syndrome from relapsing, and the first radiopharmaceutical the agency has cleared through the generic pathway. 1
Two capture boundaries shape how complete that picture is. FDA's two-week approvals report ran through September 24, so the two September 25 decisions rest on the agency's own approval notices and the sponsors' releases. On the device side, the monthly 510(k) file was refreshed on September 21 and carried item-level decisions only through September 19, while the PMA decision feed's newest entry is dated September 18. 234
At a glance
| Action | FDA date | Indication or intended use | Sponsor or applicant | What sets its scale |
|---|---|---|---|---|
| Atebrioz (zilurgisertib) | Sep. 25 | Reduce new heterotopic ossification in fibrodysplasia ossificans progressiva, ages 12 and older | Mirum Pharmaceuticals (NASDAQ: MIRM) | Third approved FOP therapy; about 300 U.S. patients; an analyst estimate near $750,000 a year and $150 million in peak worldwide sales 56 |
| Juvmo (tavapadon) | Sep. 25 | Parkinson's disease in adults | AbbVie (NYSE: ABBV) | Oral dopamine D1/D5 partial agonist; no price or sales estimate published; label breadth still unstated 17 |
| Lyrfigtu (lirafugratinib) | Sep. 23 | Previously treated FGFR2-fusion or rearranged cholangiocarcinoma | Elevar Therapeutics | Response rate 46%, median duration of response 11.8 months; about 8,000 U.S. cases a year; launch planned for the fourth quarter 89 |
| Onswik (insulin efsitora alfa-gobe) | Sep. 23 | Type 2 diabetes in adults, as once-weekly basal insulin | Eli Lilly (NYSE: LLY) | 52 injections a year instead of about 365; second weekly insulin after Novo Nordisk's Awiqli 1011 |
| Gazyva (obinutuzumab) | Sep. 25 | Relapse prevention in frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome, ages 2 and older | Genentech | First approved option for that indication; annual incidence of 1 to 4 per 100,000 children 1213 |
| Welireg (belzutifan) plus Lenvima (lenvatinib) | Sep. 24 | Advanced clear cell renal cell carcinoma after a PD-1 or PD-L1 inhibitor | Merck and Eisai | Progression-free survival 14.6 months against 10.6; overall survival missed significance 1415 |
| Olumiant (baricitinib) | Sep. 25 | Severe alopecia areata, ages 12 and older | Eli Lilly | 42% of adolescents on 4 mg reached 80% or more scalp coverage at week 36, against 5% on placebo 16 |
| Winrevair (sotatercept) | Sep. 21 | Label update adding Phase 3 HYPERION data for adults recently diagnosed with pulmonary arterial hypertension | Merck | Puts trial data in the label for patients diagnosed within the previous year 17 |
| Bravnetsa (lutetium Lu 177 dotatate) | Sep. 21 | Adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors | Lantheus (NASDAQ: LNTH) | First radioligand cleared through the generic pathway; second competing copy of the reference product this month 18 |
Novel drug approvals
Atebrioz turns off the enzyme that builds bone outside the skeleton
The FDA approved Atebrioz (zilurgisertib) on September 25 for adults and children 12 and older with fibrodysplasia ossificans progressiva, to reduce the volume of total new heterotopic ossification — bone that forms outside the skeleton. The starting dose is 100 mg by mouth once a day. 5
FOP comes from a mutation in activin A receptor type 1, and it slowly turns muscle, tendon and ligament into bone, restricting movement and shortening life. Mirum Pharmaceuticals licensed zilurgisertib from Incyte earlier this year. It is the third approved treatment, after Ipsen's Sohonos (palovarotene) in 2023 and Regeneron's Pasatru (garetosmab-grts), which FDA approved in August for adults; Atebrioz reaches down to age 12. 6
The evidence comes from PROGRESS, a randomized, double-blind, placebo-controlled trial that assigned 63 patients aged 12 and over to 100 mg of Atebrioz or placebo once daily for 24 weeks. On whole-body CT, the volume of total new heterotopic ossification fell by an average of 3.2 cm³ on the drug, against a 24.6 cm³ increase on placebo. The trial's prespecified primary endpoint was the share of patients who developed any new lesion, and that difference — one patient, or 3.1%, on Atebrioz against five, or 16.7%, on placebo — did not reach statistical significance. FDA based its efficacy assessment on the volume measure instead. 519
Headache, joint pain, upper respiratory infection, nosebleeds and nausea were the most common side effects. The label warns of harm to a fetus and restricts use with certain other medicines. FDA granted fast track, priority review and orphan drug designations. PROGRESS cohorts are still enrolling children aged 2 to 11, and the label does not cover them. 519
Commercial read
FOP is small. Mirum counts about 300 patients in the United States and 900 worldwide. The company expects to launch in October and to set its price at launch, chief executive Chris Peetz told Reuters. Citizens analyst Jonathan Wolleben estimates an annual cost near $750,000 and peak worldwide sales of about $150 million, and argues that an oral drug with this safety profile could become the preferred option over Regeneron's monthly infusion. Mirum paid Incyte $16 million upfront for the license, with milestone payments and sales royalties on top. 6
Juvmo adds an oral dopamine D1/D5 agonist for Parkinson's disease
FDA approved Juvmo (tavapadon) on September 25 to treat Parkinson's disease in adults, listing it that day as the year's forty-third novel drug. Tavapadon is a selective dopamine D1/D5 receptor partial agonist taken once daily by mouth, and AbbVie filed the application in September 2025 on results from three Phase 3 trials in the TEMPO program. 1720
The public record for this approval is thinner than for the week's other three. FDA's novel-drug table gives the indication as Parkinson's disease in adults, and leaves open whether the label covers tavapadon as initial monotherapy in early disease, as an add-on for patients whose levodopa response wears off, or both — a distinction that decides which patients a clinician can start it in. The prescribing information posted to Drugs@FDA will settle it. 12
AbbVie has announced no price or launch timing for Juvmo. What moves the commercial picture is the label's breadth, because it decides whether the drug competes as a first-line oral therapy in early Parkinson's disease or as an add-on in advanced disease. 20
Lyrfigtu is a selective FGFR2 inhibitor for bile duct cancer
FDA approved Lyrfigtu (lirafugratinib) on September 23 for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma whose tumors carry an FGFR2 gene fusion or other rearrangement. The dose is 70 mg once daily. 8
Cholangiocarcinoma, or bile duct cancer, is diagnosed in about 8,000 people in the United States each year. The approval rests on REFOCUS, an open-label single-arm trial in 116 patients who had not received an FGFR inhibitor and had already been treated with chemotherapy or chemoimmunotherapy. The objective response rate was 46% (95% CI 36–55) and median duration of response 11.8 months (95% CI 7.5–13.0). Elevar reports median progression-free survival of 11.3 months (95% CI 9.2–14.8). The label carries warnings for ocular toxicity, hyperphosphatemia and soft tissue mineralization, and harm to a fetus. 89
The eye risk is the one that changes practice. Retinal pigment epithelial detachment occurred in 31% of 385 patients treated with Lyrfigtu, at a median onset of 57 days, and the label requires an OCT scan of the macula before starting, every two months for the first 13 months and every four months afterwards. Hyperphosphatemia occurred in 21%, at a median onset of 15 days. FDA granted priority review, breakthrough therapy and orphan drug designations, and reviewed the application through its Real-Time Oncology Review pilot. 89
Commercial read
Elevar holds an exclusive worldwide license to lirafugratinib from Relay Therapeutics and expects Lyrfigtu to reach patients in the United States by the fourth quarter of 2026. Its pitch against earlier FGFR inhibitors is selectivity. Lipika Goyal of Stanford Cancer Center, the lead author on REFOCUS, describes the drug's irreversible covalent binding as producing potent and sustained FGFR2 inhibition that covers many of the resistance mutations emerging with earlier FGFR inhibitors, while sparing other FGFR isoforms. The commercial constraint is testing volume: a patient qualifies only after an FGFR2 result. 9
Onswik is the second once-weekly insulin
FDA approved Onswik (insulin efsitora alfa-gobe) on September 23 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes, injected under the skin once a week on the same day each week. It is the second once-weekly insulin approved for that population, after Novo Nordisk's Awiqli, and the label advises against use in type 1 diabetes because of an increased risk of severe low blood sugar. Lilly announced the approval on September 24, a day after the agency's own notice. 101121
Four randomized, open-label studies in more than 3,400 adults compared Onswik with once-daily insulin glargine or insulin degludec, across patients who had never used insulin, patients already on basal insulin, and patients on basal-bolus regimens; all four met their primary endpoint of non-inferior A1c reduction. In QWINT-1, A1c fell 1.19 percentage points on Onswik against 1.16 on glargine at week 52, and patients on the weekly drug needed a median of two dose adjustments against eight. Low blood sugar ran the other way by population: level 2 or 3 hypoglycemia was less frequent on Onswik than on glargine in QWINT-1 (0.50 against 0.88 events per participant-year), more frequent than degludec in QWINT-2 (0.58 against 0.45), and not significantly different in the two remaining trials. 1022
Commercial read
Lilly's selling point is the injection count, 52 a year instead of about 365, and the launch vehicle is a high-concentration pen, because a weekly dose is large. The Onswik KwikPen will arrive in two strengths, 500 units/mL and 1,000 units/mL, delivering up to 400 or 800 units in a single injection, and Lilly says it will reach the United States in the coming months. The head-to-head is with Novo Nordisk: FDA approved Awiqli in March 2026, so payers now have two weekly basal insulins to place, and the QWINT-2 hypoglycemia signal is the detail clinicians will test against Awiqli's label. 1121
Other approvals and label expansions
Gazyva becomes the first approved option against relapse in childhood nephrotic syndrome
FDA approved Gazyva (obinutuzumab) to reduce the risk of relapse in adults and children 2 years and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. Gazyva, Genentech's anti-CD20 antibody, already treats certain cancers and adults with active lupus nephritis, so this adds an indication to an existing product. Idiopathic nephrotic syndrome is the most common cause of nephrotic syndrome in children and usually begins between ages 2 and 7, with an estimated annual incidence of 1 to 4 per 100,000 children. 1213
The supporting trial, INSHORE, randomized 85 patients in complete remission to intravenous Gazyva, weight-dosed on days 1 and 15 and at weeks 24 and 26, or to twice-daily oral mycophenolate mofetil, a standard of care therapy. FDA's notice reports the proportion of patients reaching a first-morning urine protein-creatinine ratio of 0.2 g/g or less at week 52 without a relapse from week 8 as significantly greater on Gazyva than on mycophenolate mofetil, which it puts at 73%. The label carries boxed warnings for hepatitis B reactivation and progressive multifocal leukoencephalopathy, and infections, infusion-related reactions and neutropenia were the most common side effects. FDA granted breakthrough therapy, orphan drug and priority review designations. 12
Welireg plus Lenvima becomes a second-line regimen after immunotherapy in kidney cancer
FDA approved the oral combination of Welireg (belzutifan) and Lenvima (lenvatinib) on September 24 for adults with advanced renal cell carcinoma with a clear cell component whose disease progressed after a PD-1 or PD-L1 inhibitor. It is the first approved pairing of a HIF-2 alpha inhibitor with a multi-targeted VEGFR tyrosine kinase inhibitor for those patients, at 120 mg of belzutifan and 20 mg of lenvatinib once daily. 1415
LITESPARK-011 randomized 747 patients after a PD-1 or PD-L1 inhibitor to the combination or to cabozantinib. Median progression-free survival was 14.6 months against 10.6, a 26% reduction in the risk of progression or death (hazard ratio 0.74, 95% CI 0.61–0.89, p=0.001), and the objective response rate was 53% against 40%. Overall survival, the trial's other primary endpoint, did not reach statistical significance at the final analysis. Serious adverse reactions occurred in 54% of patients on the combination and fatal adverse reactions in 5%; 17% stopped belzutifan permanently and 23% stopped lenvatinib. 14
Commercial read
Cabozantinib was the trial's comparator, which makes it the incumbent this regimen has to beat in practice, and the argument for switching is progression-free survival plus a response rate 13 points higher. The overall-survival miss is what payers and competing sponsors will press on. Merck says the LITESPARK-011 results will be presented at the European Society for Medical Oncology congress in Madrid. 14
Bravnetsa is the first radioligand approved through the generic pathway
Lantheus said on September 22 that FDA granted final approval for Bravnetsa (lutetium Lu 177 dotatate), a radiopharmaceutical the agency has determined to be bioequivalent and therapeutically equivalent to the reference product Lutathera, for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. Drugs@FDA dates the abbreviated new drug application, ANDA 217060, to September 21. Lantheus describes it as the first radioligand therapy approved through the ANDA pathway, and it follows a tentative approval in March 2026. 21823
Commercial read
Bravnetsa reprices the same class from the other side of the regulatory pathway. Curium announced FDA approval of its own lutetium Lu 177 dotatate, Bexlutry, on September 14 as a radioligand equivalent, and Bravnetsa is the version that came through the generic pathway. Lantheus is also the company Curium agreed to buy on August 3 in a deal worth up to $8 billion, so if that acquisition closes, both of this month's new Lu 177 dotatate products would sit under one owner. Lantheus cites about 200,000 people in the United States living with GEP-NETs and says it is focused on a launch with reliable supply. 182425
Two more label actions
FDA widened Olumiant (baricitinib) on September 25 to pediatric patients 12 and older with severe alopecia areata. In the adolescent cohort of BRAVE-AA-PEDS, 42% of patients on the 4 mg dose and 27% on 2 mg reached a SALT score of 20 or lower at week 36, meaning 80% or more scalp hair coverage, against 5% on placebo. Olumiant has been approved for adults with severe alopecia areata since 2022, and its label keeps the boxed warning for serious infections, mortality, malignancy, major cardiovascular events and thrombosis. 16
An efficacy supplement dated September 21 adds Phase 3 HYPERION data to the Winrevair (sotatercept) label for adults diagnosed with pulmonary arterial hypertension within the previous year. 217
Other captured Drugs@FDA actions
The tables below carry the rest of the week's drug record, and the values are what the agency's report lists. 2
Original applications
| Application | Product | Dosage form | Applicant | Date | Action |
|---|---|---|---|---|---|
| ANDA 216242 | Crisaborole | Ointment, topical | Macleods Pharms Ltd | Sep. 24 | Original, ORIG-1 |
| ANDA 218355 | Ketorolac tromethamine | Injectable | Shandong | Sep. 23 | Original, ORIG-1 |
| ANDA 214598 | Mexiletine hydrochloride | Capsule, oral | Zydus Pharms | Sep. 23 | Original, ORIG-1 |
| ANDA 220876 | Norgestimate and ethinyl estradiol | Tablet, oral-28 | Annora Pharma | Sep. 23 | Original, ORIG-1 |
| ANDA 210489 | Amlodipine besylate | Tablet, oral | Ipca Labs Ltd | Sep. 22 | Original, ORIG-1 |
| ANDA 212330 | Empagliflozin | Tablet, oral | Invagen Pharms | Sep. 22 | Original, ORIG-1 |
| ANDA 220509 | Hydrocodone bitartrate and homatropine methylbromide | Tablet, oral | Senores Pharms | Sep. 22 | Original, ORIG-1 |
| ANDA 220597 | Everolimus | Tablet, for suspension | Novitium Pharma | Sep. 21 | Original, ORIG-1 |
These eight abbreviated applications add supply rather than new mechanisms: a second empagliflozin, a generic crisaborole ointment, generic norgestimate and ethinyl estradiol, and generic versions of mexiletine, ketorolac and everolimus, plus a hydrocodone-homatropine combination product. 2
Supplements
| Application | Product | Active ingredient | Sponsor | Submission | Scope | Date |
|---|---|---|---|---|---|---|
| NDA 206947 | Lenvima | Lenvatinib mesylate | Eisai | SUPPL-35 | Efficacy | Sep. 24 |
| NDA 215383 | Welireg | Belzutifan | Merck Sharp Dohme | SUPPL-13, SUPPL-17 | Efficacy, labeling | Sep. 24 |
| BLA 761363 | Winrevair | Sotatercept-csrk | Merck Sharp Dohme | SUPPL-12, SUPPL-16, SUPPL-17 | Efficacy, labeling | Sep. 21 |
| ANDA 074626 | Butorphanol tartrate preservative free | Butorphanol tartrate | Hospira | SUPPL-43 | Labeling | Sep. 24 |
| NDA 213645 | Daptomycin in 0.9% sodium chloride | Daptomycin | Baxter Hlthcare Corp | SUPPL-4 | Labeling | Sep. 24 |
| NDA 050547 | Claforan | Cefotaxime sodium | Sterimax | SUPPL-72 | Labeling | Sep. 23 |
| NDA 021366 | Crestor | Rosuvastatin calcium | Astrazeneca | SUPPL-48 | Labeling | Sep. 23 |
| ANDA 074305 | Glipizide | Glipizide | Aiping Pharm Inc | SUPPL-33 | Manufacturing (CMC) | Sep. 23 |
| NDA 020031, NDA 020710, NDA 020936 | Paxil, Paxil CR | Paroxetine hydrochloride | Apotex | SUPPL-81, SUPPL-49, SUPPL-62 | Labeling | Sep. 23 |
| BLA 761143 | Tepezza | Teprotumumab-trbw | Horizon Therapeutics Ireland | SUPPL-33 | Labeling | Sep. 23 |
| NDA 214324 | Tyvaso DPI | Treprostinil | United Therap | SUPPL-7 | Labeling | Sep. 23 |
| ANDA 219239 | Epinephrine | Epinephrine | Gland | SUPPL-2 | Manufacturing (CMC) | Sep. 22 |
| ANDA 091558 | Mycophenolate sodium | Mycophenolate sodium | Apotex Inc | SUPPL-27, SUPPL-30 | Labeling | Sep. 22 |
| NDA 212099 | Nubeqa | Darolutamide | Bayer Healthcare | SUPPL-16 | Labeling | Sep. 22 |
| ANDA 090807 | Pantoprazole sodium | Pantoprazole sodium | Rubicon Research | SUPPL-14 | Labeling | Sep. 22 |
| NDA 209139 | Prexxartan | Valsartan | Carmel Biosciences | SUPPL-4 | Labeling | Sep. 22 |
| ANDA 090681 | Quetiapine fumarate | Quetiapine fumarate | Accord Hlthcare | SUPPL-17 | Labeling | Sep. 22 |
| ANDA 077328 | Risperidone | Risperidone | Senores Pharms | SUPPL-16 | Manufacturing (CMC) | Sep. 22 |
| NDA 215358 | Scemblix | Asciminib hydrochloride | Novartis | SUPPL-15 | Labeling | Sep. 22 |
| ANDA 205234 | Telmisartan and amlodipine | Amlodipine besylate; telmisartan | Alembic | SUPPL-3 | Manufacturing (CMC) | Sep. 22 |
| ANDA 090779 | Acetazolamide | Acetazolamide | Indicus Pharma | SUPPL-7, SUPPL-12 | Labeling | Sep. 21 |
| ANDA 090161 | Divalproex sodium | Divalproex sodium | Dr Reddys Labs Ltd | SUPPL-26, SUPPL-27 | Labeling | Sep. 21 |
| ANDA 203088 | Duloxetine hydrochloride | Duloxetine hydrochloride | Breckenridge | SUPPL-42 | Manufacturing (CMC) | Sep. 21 |
| ANDA 090688 | Nevirapine | Nevirapine | Macleods Pharms | SUPPL-18 | Labeling | Sep. 21 |
| ANDA 206801, ANDA 206802 | Palonosetron hydrochloride | Palonosetron hydrochloride | Fresenius Kabi Usa | SUPPL-2 | Labeling | Sep. 21 |
| ANDA 090682 | Valacyclovir hydrochloride | Valacyclovir hydrochloride | Aurobindo Pharma | SUPPL-27 | Labeling | Sep. 21 |
The three efficacy rows are the combination and label expansions described above; the remaining rows are labeling and manufacturing updates. 2
Two approvals FDA posted too late for them to have appeared in the September 12–18 issue fall inside that earlier window, and belong on the record anyway. An efficacy supplement for Aqneursa (levacetylleucine) carries a September 18 date, and the agency's notice describes it as an approval for ataxia in patients with ataxia-telangiectasia. An efficacy supplement for Kerendia (finerenone) is dated September 16, and trade coverage describes it as an approval covering chronic kidney disease in people with type 1 diabetes, backed by a 28% reduction in urine albumin-to-creatinine ratio at six months in the FINE-ONE trial. 22627
Medical devices
The device half of this week is thinner than the drug half, and the capture boundary explains why. The monthly 510(k) file FDA refreshed on September 21 carried item-level decisions through September 19, and the PMA decision feed's newest entry was dated September 18. 34
Clearances dated September 19
| Number | Device | Applicant | Product code | Review |
|---|---|---|---|---|
| K252723 | Dynamis Pro family | Fotona D.O.O., Ljubljana | GEX | Traditional, General Surgery panel 28 |
| K261859 | Electric scooter (FDB08, FDB08A, FDB12) | Anhui JBH Medical Apparatus Co., Ltd., Chuzhou | INI | Traditional, Physical Medicine panel 29 |
Those two are the only item-level device decisions the official records carry inside this window. Recent 510(k) records carry the applicant and decision date without summary text or a statement of intended use, so the cleared scope of a fresh clearance rests on the classification entry alone. 2829
The September 14–18 clearances the last issue could not see
The refreshed file now carries the four clearances the September 12–18 issue reported from their applicants' announcements, and FDA's own decision dates run earlier than the announcements: Medtronic's LigaSure RAS Maryland instrument was announced for September 16 and dated September 15, Microstructure Imaging's MICSI-PET was reported September 16 and dated September 11, Beta Bionics's Mint was announced September 14 and dated September 11, and Pace Surgical's Tempo system was announced September 17 and dated September 3. 30313233
| Number | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|
| K261070 | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, nano-coated | Covidien, LLC | Sep. 15 | GEI |
| K261305 | MICSI-PET | Microstructure Imaging, Inc. | Sep. 11 | KPS |
| K260001 | Mint ACE Pump | Beta Bionics, Inc. | Sep. 11 | QFG |
| K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | Sep. 3 | HRS |
The same file carries 80 further clearances dated September 14 through 18, which the last issue's window covered but its file had not yet picked up. Among them are Ethicon Endo-Surgery's HARMONIC 1100 Shears (K254196), Abbott Medical's EnSite X EP System (K261729), Medtronic's Protégé EverFlex self-expanding peripheral stent (K262913), Fujifilm's APERTO Lucent MRI system (K261283), Ceribell's EEG analysis software (K261712), Elucid Bioimaging's PlaqueIQ (K261855), Epic Systems' Deterioration Index Version 2 (K260008) and Biolinq's Shine microsensor (K262599). 3
The PMA feed, which the September 12–18 issue read as showing nothing after September 13, now carries 46 decisions dated September 14 through 18 and nothing dated September 19 or later. Two of those 46 are original premarket approvals: P250041, MedAlliance's SELUTION SLR 014 PTCA drug-eluting balloon, dated September 18, and P250046, Promega's OncoMate MSI Dx Analysis System, dated September 15. 43435
What matters next
- Atebrioz's price and payer path. Mirum launches in October and sets the price then; watch whether payers accept an annual cost near $750,000 for a drug whose prespecified primary endpoint missed, and whether the company sells, holds or transfers any priority review voucher.
- The depth of Juvmo's label. Whether it covers tavapadon as monotherapy, as an add-on for patients with motor fluctuations, or both determines which patients a clinician can start it in, and therefore how large the market is. AbbVie has not yet published a price.
- Two weekly insulins, one formulary. Onswik against Novo Nordisk's Awiqli will be decided on hypoglycemia rates by patient type and on coverage, since A1c results were similar across the QWINT trials.
- Lu 177 dotatate consolidation. With Bravnetsa approved and Curium's Bexlutry already on the market, the open questions are pricing and whether Curium's pending acquisition of Lantheus clears.
- Device ledger recheck. The next issue should capture 510(k) decisions dated September 20 or later, and any PMA decision after September 18, against the refreshed monthly file and the feed.
References
- 1
- 2Recent New and Generic Drug Approvals
accessdata.fda.gov
- 3Downloadable 510(k) Files
fda.gov
- 4FDA PMA Decisions Feed
accessdata.fda.gov
- 5
- 6
- 7
- 8
- 9Elevar Therapeutics Announces FDA Approval of Lyrfigtu
globenewswire.com
- 10
- 11
- 12
- 13
- 14
- 15
- 16
- 17
- 18Lantheus Receives Final FDA Approval for BRAVNETSA
investor.lantheus.com
- 19
- 20
- 21U.S. Food and Drug Administration (FDA) approves Lilly's Onswik
investor.lilly.com
- 22
- 23Lantheus Receives FDA Tentative Approval for Lutetium Lu 177 Dotatate (PNT2003)
lantheusholdings.gcs-web.com
- 24Curium announces FDA approval of BEXLUTRY
biospace.com
- 25
- 26
- 27
- 28FDA 510(k) record K252723
accessdata.fda.gov
- 29FDA 510(k) record K261859
accessdata.fda.gov
- 30FDA 510(k) record K261070
accessdata.fda.gov
- 31FDA 510(k) record K261305
accessdata.fda.gov
- 32FDA 510(k) record K260001
accessdata.fda.gov
- 33FDA 510(k) record K261647
accessdata.fda.gov
- 34FDA PMA record P250041
accessdata.fda.gov
- 35FDA PMA record P250046
accessdata.fda.gov
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