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. Four approvals in this table are already effective but have not yet appeared on FDA’s own 2026 listing page. Individual drug analyses live in our FDA Novel Drugs library.

Data verified 4 August 2026FDA page last updated 7 July 2026Entries 28

28Novel drugs approved

4Not yet on FDA page

6Accelerated approvals

9Biologics

6Oncology approvals

5July approvals alone

Distribution

The shape of 2026 so far

May was the densest month of the year with eight clearances in a single 30-day window, five of them between 22 and 29 May. July recovered the pace after a quiet April. Small molecules still carry roughly two-thirds of the year, but the biologic share is concentrated in rare disease and oncology.

Approvals by month

January1

February4

March5

April2

May8

June3

July5

By therapeutic area

Oncology6

Infection4

Rare disease4

Cardiometab4

Hepatology2

Dermatology2

Psychiatry2

Other4

By modality

Small molecule18

Biologic9

Other1

Update log

What changed since the last revision of this page

The previous version of this tracker closed at 23 approvals on 26 June 2026. Five clearances have landed since. Only the first of them, Trutakna, has been added to FDA’s own 2026 listing page, which itself has not been touched since 7 July. The remaining four are confirmed against FDA drug-approval notices and FDA press announcements but are still absent from that summary table, so this page runs four entries ahead of the source it summarises.

7 July · on FDA page as no. 24Trutakna (atacicept-vymj)First and only dual BAFF and APRIL inhibitor cleared for IgA nephropathy. Accelerated approval on a proteinuria surrogate: the ORIGIN 3 interim showed a 42 percent reduction against placebo at week 36. Continued approval depends on confirmatory eGFR data. It enters a field that already includes Voyxact (sibeprenlimab), and our full Trutakna analysis covers ORIGIN 3, safety and pricing in depth.

14 July · pending FDA listingRevtorpyk (gedatolisib)The only approved inhibitor covering all four class I PI3K isoforms plus mTORC1 and mTORC2. Approved with fulvestrant, with or without palbociclib, in HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer. Celcuity has signalled an sNDA for the PIK3CA-mutant cohort in Q3. FDA approval notice.

16 July · pending FDA listingLipfendra (enlicitide)The commercially significant approval of the year. A macrocyclic peptide taken as a 20 mg once-daily tablet, and the first oral PCSK9 inhibitor in a class that had only ever existed as injections. Placebo-adjusted LDL-C reduction of 56 to 59 percent at week 24. Cardiovascular outcomes remain unproven pending CORALreef Outcomes. FDA announcement.

22 July · pending FDA listingJideytro (zidesamtinib)ROS1-selective TKI for previously treated ROS1-positive NSCLC, cleared roughly two months ahead of the goal date through Real-Time Oncology Review. Originated at Nuvalent; GSK closed its acquisition of Nuvalent on 15 July, one week before approval. FDA approval notice.

24 July · pending FDA listingSimtriyo (centanafadine)First norepinephrine, dopamine and serotonin reuptake inhibitor approved for ADHD, in adults and children aged 6 and over weighing at least 20 kg. A genuinely new mechanism in a category that has been static for years. Otsuka announcement.

Practical caution for anyone compiling their own list: several widely circulated July approvals are not CDER novel drugs and should not be counted here. Sarclisa Escena is a new route for an already approved isatuximab; Lytenava is bevacizumab, approved since 2004; Tylenol with Naproxen is an OTC combination of two long-approved actives; Ranluspec is a biosimilar; Cavhanza is a reformulated nilotinib; and Tregzi, the Orca-T cell therapy, is regulated by CBER and never appears on the CDER novel list.

Full dataset

All 28 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. Rows tinted in clay are approved and effective but not yet reflected on FDA’s 2026 summary page. Drug names shown as gold-underlined links open our full analysis of that approval.

Showing 28 of 28 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	RevtorpykPending FDA listing	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	LipfendraPending FDA listing	enlicitide	16 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	JideytroPending FDA listing	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
28	SimtriyoPending FDA listing	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

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

Why does this page show 28 approvals when FDA’s own page shows 24?

FDA’s Novel Drug Approvals for 2026 summary page is maintained in batches rather than updated on the day of each action. Its content-current date is 7 July 2026, so it stops at Trutakna. Four novel drugs have been approved since and each is independently confirmed through FDA’s own drug approval notices and press announcements. They are legally approved and marketable now; they are simply awaiting addition to that one summary table. Expect FDA’s count to catch up to 28 in its next refresh.

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. 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 and Awiqli the first once-weekly basal insulin, both of which 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 4 August 2026. Because FDA’s own summary page lags actual approval actions by several weeks, this tracker is deliberately maintained ahead of it, with any entry not yet reflected on the FDA page clearly flagged rather than silently merged.

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Sources

FDA, Novel Drug Approvals for 2026, Center for Drug Evaluation and Research (content current as of 7 July 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).
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.

Compiled by Darshan Singh for Laafon Galaxy Pharmaceuticals. Twenty-three years in pharmaceutical quality control, quality assurance and drug regulatory affairs. Verified 4 August 2026.