Live regulatory tracker · CDER novel approvals

FDA New Drug List 2026: Novel Drug Approvals and Key Insights

Every new molecular entity and new therapeutic biologic cleared by FDA’s Center for Drug Evaluation and Research in 2026, with sponsor, modality, expedited pathway and approved use. Searchable, sortable and filterable. FDA has now fully caught up on its own 2026 listing page, so this table is in exact sync with the agency count and numbering. Individual drug analyses live in our FDA Novel Drugs library.

Data verified 21 August 2026FDA page last updated 19 August 2026Entries 33

33Novel drugs approved

5Added this update

7Accelerated approvals

11Biologics

7Oncology approvals

4August approvals

Distribution

The shape of 2026 so far

May remains the densest month with eight clearances in a single 30-day window, five of them between 22 and 29 May, but July came close with six and August has produced four in its first three weeks. Oncology has overtaken every other area. Small molecules still carry roughly two-thirds of the year, while the biologic share stays concentrated in rare disease, oncology and ophthalmology.

Approvals by month

January1

February4

March5

April2

May8

June3

July6

August4

By therapeutic area

Oncology7

Rare disease5

Other6

Infection4

Cardiometab4

Psych / neuro3

Hepatology2

Dermatology2

By modality

Small molecule21

Biologic11

Other1

Update log

What changed since the last revision of this page

The previous revision closed at 28 entries on 4 August. Five approvals have been added since, four of them in August alone. The more consequential change is structural: FDA refreshed its own listing on 19 August and has now caught up completely, so the “pending FDA listing” flags that ran on four rows through July have all been cleared and this table matches FDA’s numbering exactly, 1 through 33.

19 August · FDA no. 33Pasatru (garetosmab-grts)A fully human monoclonal antibody blocking Activin A, and the first approved treatment for fibrodysplasia ossificans progressiva, an ultra-rare disorder in which soft tissue progressively ossifies into bone. Indicated to reduce new heterotopic ossification and clinician-assessed flare-ups in adults.

13 August · FDA no. 32Zenbexus (iberdomide)A cereblon-modulating protein degrader, approved under accelerated approval with daratumumab and hyaluronidase-fihj plus dexamethasone for multiple myeloma after at least one prior line including a proteasome inhibitor and an immunomodulatory agent. The seventh accelerated approval of the year.

13 August · FDA no. 31Tauklarify (florquinitau F 18)An F18-labelled tau PET imaging agent for adults with cognitive impairment under evaluation for Alzheimer disease, identifying tau neurofibrillary tangle pathology. A diagnostic rather than a therapeutic, but it counts as a novel drug because the active moiety is new.

5 August · FDA no. 30Orzeyful (oveporexton)An orexin receptor 2 agonist for narcolepsy type 1, and the first approved agent to address the underlying orexin deficiency rather than managing daytime sleepiness or cataplexy symptomatically. A mechanistically new category, not an incremental entrant.

24 July · FDA no. 28 · correctionLytenava (bevacizumab-vikg)Added after review. The previous revision of this page excluded Lytenava on the reasoning that bevacizumab has been approved since 2004. FDA counts it as a novel drug: bevacizumab-vikg is a distinct ophthalmic biologic approved under its own BLA with its own suffix, and it is the first bevacizumab formulated and approved for intravitreal use in wet age-related macular degeneration. FDA’s classification governs, and this page now follows it.

Practical caution for anyone compiling their own list: eight approvals since late June are not CDER novel drugs and should not be counted. Genglycos and Tudriqev are CBER gene and oncolytic viral therapies, mFLUSIVA is a CBER vaccine, Tregzi is a CBER cell therapy, Garzulys is a biosimilar to NovoLog, Sarclisa Escena is a subcutaneous route for already-approved isatuximab, and Gwyn Lo and Tylenol with Naproxen are combinations of long-approved actives. The Lytenava case above cuts the other way and is the subtler trap: an active ingredient that sounds familiar can still be a novel biologic under a separate BLA.

Full dataset

All 33 novel approvals, January to August 2026

Search across drug name, active ingredient, sponsor, therapeutic area and approved use. On desktop, click any column header to sort. Numbering matches FDA’s own list exactly. Drug names shown as underlined links open our full analysis of that approval.

Showing 33 of 33 approvals

FDA CDER novel drug approvals for 2026, listing number, drug name, active ingredient, approval date, sponsor, therapeutic area, modality, expedited pathway designations and approved use
No. ↕	Drug ↕	Active ingredient ↕	Approval date ↕	Sponsor ↕	Therapeutic area ↕	Modality ↕	Designations	FDA-approved use on approval date
1	Zycubo full analysis	copper histidinate	12 Jan 2026	Sentynl Therapeutics (Zydus Lifesciences)	Rare Disease / Metabolic	Metal replacement therapy	Priority ReviewBreakthroughFast TrackOrphan DrugRare Pediatric	To treat Menkes disease
2	Adquey full analysis	difamilast	12 Feb 2026	Acrotech Biopharma / Otsuka	Dermatology	Topical PDE-4 inhibitor	—	To treat mild to moderate atopic dermatitis
3	Bysanti full analysis	milsaperidone	20 Feb 2026	Vanda Pharmaceuticals	Psychiatry	Atypical antipsychotic	—	To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder
4	Loargys full analysis	pegzilarginase-nbln	23 Feb 2026	Immedica Pharma	Rare Disease / Metabolic	PEGylated enzyme replacement	Accelerated ApprovalBreakthroughFast TrackOrphan DrugRare Pediatric	To treat hyperarginemia in adults and pediatric patients two years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction
5	Yuviwel full analysis	navepegritide	27 Feb 2026	Ascendis Pharma	Rare Disease / Endocrine	CNP analog prodrug	Accelerated ApprovalPriority ReviewRare Pediatric (PRV)	To increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses
6	Lynavoy full analysis	linerixibat	17 Mar 2026	GSK	Hepatology	IBAT inhibitor	—	To treat cholestatic pruritus associated with primary biliary cholangitis
7	Icotyde	icotrokinra	17 Mar 2026	Johnson and Johnson	Dermatology	Oral IL-23 receptor peptide antagonist	—	To treat moderate-to-severe plaque psoriasis in patients 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy
8	Avlayah	tividenofusp alfa-eknm	24 Mar 2026	Denali Therapeutics	Rare Disease / Neurology	Enzyme replacement, BBB transport fusion	Accelerated ApprovalBreakthroughFast TrackOrphan DrugRare Pediatric (PRV)	To treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II)
9	Lifyorli	relacorilant	25 Mar 2026	Corcept Therapeutics	Oncology	Selective glucocorticoid receptor antagonist	—	To treat platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer after one to three prior systemic regimens, at least one of which included bevacizumab
10	Awiqli	insulin icodec-abae	26 Mar 2026	Novo Nordisk	Endocrinology	Once-weekly basal insulin analog	—	To improve glycemic control in adults with type 2 diabetes mellitus
11	Foundayo	orforglipron	1 Apr 2026	Eli Lilly	Endocrinology / Obesity	Oral GLP-1 receptor agonist	National Priority Voucher	To reduce excess body weight and maintain weight reduction long term in adults with obesity, or adults with overweight plus at least one weight-related comorbidity, with reduced-calorie diet and increased physical activity
12	Idvynso	doravirine and islatravir	20 Apr 2026	Merck	Infectious Disease	Two-drug antiretroviral combination	—	To treat HIV-1 infection as a complete regimen in virologically suppressed adults replacing a stable antiretroviral regimen, with no history of virologic failure and no known doravirine resistance substitutions
13	Veppanu	vepdegestrant	1 May 2026	Arvinas / Pfizer	Oncology	First approved PROTAC degrader	—	To treat ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with progression after at least one line of endocrine therapy
14	Beqalzi	sonrotoclax	13 May 2026	BeOne Medicines	Oncology	Next-generation BCL2 inhibitor	Accelerated ApprovalBreakthroughFast TrackOrphan Drug	To treat adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a Bruton tyrosine kinase inhibitor
15	Baxfendy	baxdrostat	15 May 2026	AstraZeneca	Cardiovascular	First-in-class aldosterone synthase inhibitor	—	To treat hypertension in combination with other antihypertensive drugs
16	Hepcludex	bulevirtide-gmod	22 May 2026	Gilead Sciences	Hepatology / Infectious Disease	Lipopeptide viral entry inhibitor	Accelerated Approval	To treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis
17	Decnupaz	pivekimab sunirine-pvzy	27 May 2026	AbbVie	Oncology	CD123-directed antibody-drug conjugate	Priority ReviewBreakthroughOrphan Drug	To treat adults with blastic plasmacytoid dendritic cell neoplasm
18	Zaynich	cefepime and zidebactam	29 May 2026	Wockhardt	Infectious Disease	Cephalosporin plus beta-lactamase inhibitor	—	To treat complicated urinary tract infections including pyelonephritis caused by designated susceptible microorganisms
19	Xocova	ensitrelvir	29 May 2026	Shionogi	Infectious Disease	Oral 3CL protease inhibitor	—	Post-exposure prophylaxis of COVID-19 following contact with an individual who has COVID-19
20	Cypsedo	cipepofol	29 May 2026	Haisco Pharmaceutical Group	Anesthesiology	GABA-A modulator, propofol analog	—	To induce general anesthesia in adults undergoing surgery
21	Ambelvist	gadoquatrane	12 Jun 2026	Bayer HealthCare	Radiology / Diagnostics	Macrocyclic gadolinium contrast agent	—	To detect and visualize lesions with abnormal vascularity, in conjunction with MRI
22	Utebzi full analysis	tebipenem pivoxil	17 Jun 2026	GSK (Spero Therapeutics)	Infectious Disease	Oral carbapenem antibiotic	QIDPFast Track	To treat complicated urinary tract infections including pyelonephritis in adults with limited or no alternative oral treatment options
23	Lumvoa full analysis	veligrotug-vvze	26 Jun 2026	Viridian Therapeutics	Ophthalmology / Autoimmune	IGF-1R antagonist antibody	Priority Review	To treat thyroid eye disease
24	Trutakna full analysis	atacicept-vymj	7 Jul 2026	Vera Therapeutics	Nephrology	Recombinant BAFF and APRIL fusion protein	Accelerated ApprovalPriority ReviewBreakthrough	To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression
25	Revtorpyk	gedatolisib	14 Jul 2026	Celcuity	Oncology	Pan class I PI3K plus mTORC1/2 inhibitor	—	In combination with fulvestrant, with or without palbociclib, to treat HR-positive, HER2-negative, PIK3CA wild-type locally advanced or metastatic breast cancer after progression on at least one line of endocrine therapy in the metastatic setting
26	Lipfendra	enlicitide	15 Jul 2026	Merck	Cardiovascular	Oral macrocyclic peptide PCSK9 inhibitor	National Priority Voucher	As an adjunct to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia
27	Jideytro	zidesamtinib	22 Jul 2026	Nuvalent (GSK)	Oncology	ROS1-selective kinase inhibitor	BreakthroughOrphan DrugReal-Time Oncology Review	To treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who received at least one prior ROS1 tyrosine kinase inhibitor
29	Simtriyo	centanafadine	24 Jul 2026	Otsuka	Psychiatry	Norepinephrine, dopamine, serotonin reuptake inhibitor	Priority Review	To treat attention-deficit hyperactivity disorder in adults and pediatric patients aged 6 years and older weighing at least 20 kg
28	Lytenava	bevacizumab-vikg	24 Jul 2026	Outlook Therapeutics	Ophthalmology	Intravitreal VEGF inhibitor antibody	—	To treat patients with neovascular (wet) age-related macular degeneration
30	Orzeyful	oveporexton	5 Aug 2026	Takeda	Neurology / Sleep Medicine	Orexin receptor 2 agonist	—	To treat narcolepsy type 1
31	Tauklarify	florquinitau F 18	13 Aug 2026	Lantheus Holdings	Radiology / Diagnostics	F18-labelled tau PET radiodiagnostic	—	For positron emission tomography of the brain in adults with cognitive impairment being evaluated for Alzheimer disease, to identify patients with tau neurofibrillary tangle pathology
32	Zenbexus	iberdomide	13 Aug 2026	Bristol Myers Squibb	Oncology	Cereblon-modulating protein degrader	Accelerated Approval	In combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent
33	Pasatru	garetosmab-grts	19 Aug 2026	Regeneron Pharmaceuticals	Rare Disease / Musculoskeletal	Anti-Activin A monoclonal antibody	—	To reduce new heterotopic ossification and clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva

Reading the approved use column. These are FDA’s presentation-level summaries of the indication on the approval date, not the full conditions of use. Populations, dosing regimens, limitations of use and safety labelling live in the current Prescribing Information at Drugs@FDA, which supersedes anything summarised here and may already have been revised.

Go deeper

Full analyses of individual 2026 approvals

Each of these covers mechanism, pivotal trial design and endpoints, safety profile, dosing, and access and pricing in detail. More are published as approvals land; the complete set lives in the FDA Novel Drugs library.

Trutakna (atacicept-vymj)Dual BAFF and APRIL blockade in IgA nephropathy, ORIGIN 3 evidence and the surrogate-endpoint question Lumvoa (veligrotug-vvze)IGF-1R antagonist antibody for thyroid eye disease Utebzi (tebipenem pivoxil)Oral carbapenem for complicated UTI, and what QIDP status actually confers Lynavoy (linerixibat)IBAT inhibition for cholestatic pruritus in primary biliary cholangitis Yuviwel (navepegritide)Once-weekly CNP prodrug for achondroplasia in children with open epiphyses Loargys (pegzilarginase-nbln)PEGylated enzyme replacement for Arginase 1 Deficiency Bysanti (milsaperidone)New atypical antipsychotic for schizophrenia and bipolar I Adquey (difamilast)Topical PDE-4 inhibitor for mild to moderate atopic dermatitis Zycubo (copper histidinate)Survival benefit in Menkes disease, and the rare pediatric voucher economics

Regulatory literacy

The four pathway labels in this table, and what each one actually commits FDA to

These designations are routinely conflated in trade coverage. They are separate mechanisms with different evidentiary consequences, and only one of them changes the standard of evidence required for approval. More US regulatory explainers sit in our USFDA section.

Accelerated Approval

The only one of the four that alters the evidence standard. Approval rests on a surrogate endpoint reasonably likely to predict clinical benefit, with a confirmatory trial obligation attached. Withdrawal procedures apply if that trial fails or is not completed with due diligence. Six of the 28 approvals here sit on this pathway.

Loargys · Yuviwel · Avlayah · Beqalzi · Hepcludex · Trutakna

Priority Review

Purely a clock mechanism. It compresses FDA’s review goal from ten months to six months from the 60-day filing date. The evidentiary bar for approval is unchanged. A drug can hold Priority Review and still be denied.

Zycubo · Yuviwel · Decnupaz · Lumvoa · Trutakna · Simtriyo

Breakthrough Therapy

A process designation granted on preliminary clinical evidence of substantial improvement over available therapy on a clinically significant endpoint. It buys intensive FDA guidance and organisational commitment, not a lowered standard. It is frequently held alongside Accelerated Approval, which is why the two get confused.

Zycubo · Loargys · Avlayah · Beqalzi · Decnupaz · Trutakna · Jideytro

Commissioner’s National Priority Voucher

The newest and least settled of the four. A pilot that compresses review to a matter of weeks for products FDA designates as national priorities. Foundayo cleared in roughly 50 days under it and Lipfendra also moved through it. The programme has drawn calls for reform and its long-run criteria are not yet fixed, so treat CNPV status as a signal about review speed only, never about evidentiary strength.

Foundayo · Lipfendra

Common questions

FDA novel drug approvals 2026: questions we get asked

Is this page in sync with FDA’s own list?

Yes, as of this revision. FDA refreshed its Novel Drug Approvals for 2026 page on 19 August 2026 and it now carries all 33 entries. Our numbering matches FDA’s exactly. That will not always hold: FDA maintains that page in batches rather than on the day of each action, and through July this tracker ran four entries ahead of it. When that happens again, the affected rows are flagged rather than quietly merged, so you can always tell which entries FDA has formally listed and which are approved but awaiting listing.

What exactly qualifies as a novel drug?

A novel drug is a new molecular entity approved under an NDA, or a new therapeutic biologic approved under a BLA, where the active ingredient has never previously been approved or marketed in the United States, and where the product is regulated by CDER. That definition excludes a great deal of what trade press calls a new approval: new salts, new routes of administration, new fixed-dose combinations of approved actives, biosimilars, reformulations, and cell and gene therapies regulated by CBER. It is the single most common source of inflated 2026 approval counts. The reverse error is subtler and caught this page out in August: Lytenava contains bevacizumab, approved since 2004, yet FDA counts it as novel because bevacizumab-vikg is a separate ophthalmic biologic under its own BLA with its own suffix. A familiar-sounding active ingredient does not automatically disqualify a product. You can confirm any individual product’s status at Drugs@FDA.

Which 2026 approvals matter most commercially?

On volume potential, Lipfendra and Foundayo. Lipfendra converts an injection-only class into a once-daily tablet in a population measured in tens of millions, though it has to be taken on an empty stomach and its cardiovascular outcomes data is still pending. Foundayo is the first small-molecule GLP-1 receptor agonist for weight management. On scientific significance rather than revenue, Veppanu is the first approved PROTAC degrader, Awiqli the first once-weekly basal insulin, and Orzeyful the first agent to treat the orexin deficiency underlying narcolepsy type 1 rather than manage its symptoms. All three open categories rather than extending them.

Is any of this relevant to an Indian manufacturer or exporter?

Directly, in two ways. First, Indian sponsors are on this list: Wockhardt’s Zaynich is a fully India-originated NCE combination approved for complicated UTIs, and Zycubo is commercialised through Zydus Lifesciences’ Sentynl. That is a meaningful precedent for domestic NCE programmes rather than generics alone. Second, every novel approval starts a patent and exclusivity clock that eventually determines ANDA and 505(b)(2) filing windows, so the 2026 list is the front end of the generic pipeline your business development team will be looking at five to twelve years from now. If you are building toward regulated-market supply, the working constraints are domestic first: see our CDSCO Revised Schedule M compliance dashboard and our third-party manufacturing guidance.

How often is this tracker updated?

It is reconciled against FDA’s Novel Drug Approvals for 2026 page, FDA drug approval notices, FDA press announcements and sponsor releases. This revision was verified on 21 August 2026. FDA’s summary page lags actual approval actions by up to several weeks between refreshes, so this tracker is maintained ahead of it, with any entry not yet reflected on the FDA page clearly flagged rather than silently merged. At the current run rate of roughly four novel approvals a month, 2026 is tracking toward the high forties.

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Sources

FDA, Novel Drug Approvals for 2026, Center for Drug Evaluation and Research (content current as of 19 August 2026).
FDA drug approval notices: gedatolisib, 14 July 2026 and zidesamtinib, 22 July 2026.
FDA announcement of the first oral PCSK9 inhibitor, 16 July 2026.
Sponsor announcements: Vera Therapeutics (7 July), Celcuity (14 July), Merck (16 July), GSK (22 July), Otsuka (24 July).
Approval dates and numbering for entries 28 to 33 cross-checked against the FDA listing and Drugs.com New Drug Approvals, which tracks approval actions between FDA page refreshes.
Drugs@FDA for current Prescribing Information on every product listed.

This tracker is prepared for pharmaceutical, regulatory and business-development professionals. It summarises publicly available regulatory actions and is not medical advice, prescribing guidance or a substitute for the approved Prescribing Information. Approval status, indications and labelling change; always verify against Drugs@FDA before relying on any entry. Where this page runs ahead of FDA’s own summary listing, that is stated explicitly on the affected rows; at this revision it does not, and the table matches FDA numbering exactly.

Compiled by Darshan Singh for Laafon Galaxy Pharmaceuticals. Twenty-three years in pharmaceutical quality control, quality assurance and drug regulatory affairs. Verified 21 August 2026.