83 applications are under active FDA review with a published goal date. 6 of them resolve inside 45 days, and the calendar now runs to June 2027.
2 reviews are past their goal date with no announced decision. A missed goal date is not an administrative footnote — it usually signals an unresolved review issue, and those are the rows worth watching most closely.
7 applications are in a repeat review cycle — each carries a prior complete response or refuse-to-file letter followed by an accepted resubmission. They read as dead to any filter that stops at the first rejection, and they are live.
Confidence is stated per row. 35 rows carry an exact published goal date; 48 rest on a month-level or 'or earlier' estimate and should not be treated as fixed. No row ships unconfirmed.
| Goal date | Ticker | Drug | Sponsor | Indication | Conf. |
|---|---|---|---|---|---|
| 2026-08-13 | LNTH | MK-6240 (F18 tau PET agent) | Lantheus / Cerveau | Tau NFT pathology imaging in Alzheimer's evaluation | estimated |
| 2026-08-17 | BMY | Iberdomide | Bristol Myers Squibb | Relapsed/refractory multiple myeloma (IberDd regimen) | confirmed |
| 2026-08-22 | CAPR | Deramiocel (CAP-1002) | Capricor Therapeutics / Nippon Shinyaku | Duchenne muscular dystrophy cardiomyopathy | confirmed |
| 2026-08-23 | RARE | Pariglasgene brecaparvovec (DTX401) | Ultragenyx | Glycogen Storage Disease Type Ia (GSDIa) | confirmed |
| 2026-08-24 | BIIB | Leqembi Iqlik (lecanemab SC) | Eisai / Biogen | Early Alzheimer's disease — SC starting dose | estimated |
| 2026-08-25 | JAZZ | Ziihera (zanidatamab-hrii) | Jazz Pharmaceuticals / BeOne | Cancer | confirmed |
| 2026-08-27 | GILD | Bictegravir/lenacapavir (BIC/LEN) | Gilead Sciences | HIV-1 in virologically suppressed adults | confirmed |
| 2026-09-27 | RHHBY | Gazyva (obinutuzumab) | Genentech (Roche) / Biogen | Renal, Immunology | confirmed |
| 2026-10-28est | NVS | Ianalumab (VAY736) | Novartis | Immunology | estimated |
| 2026-10-29 | N/A | Lucamzi (ranibizumab biosimilar) | Xbrane / Stada | Ophthalmology | estimated |
| 2026-10-29 | N/A | Ilumya (tildrakizumab-asmn) | Sun Pharma | Dermatology, Immunology | confirmed |
| 2026-10-30 | INO | INO-3107 | Inovio | Infectious Disease | confirmed |
| 2026-11-01 | AGIO | Mitapivat (Pyrukynd / Aqvesme) | Agios Pharmaceuticals | Blood Disorders | estimated |
| 2026-11-01 | REGN | Cemdisiran | Regeneron | CNS, Immunology | estimated |
| 2026-11-15 | RHHBY | Gazyva (obinutuzumab) | Genentech (Roche) / Biogen | Renal, Immunology | confirmed |
| 2026-11-17 | N/A | Adrabetadex (VTS-270) | Mandos (Beren Therapeutics) | CNS, Inborn Errors | confirmed |
| 2026-11-19est | BAYRY | Asundexian | Bayer | CNS | estimated |
| 2026-11-22est | PFE | Talzenna (talazoparib) | Pfizer | Cancer | estimated |
| 2026-11-22 | SVRA | Molbreevi (molgramostim) | Savara | Respiratory | confirmed |
| 2026-11-25 | SNY | Venglustat | Sanofi | Inborn Errors | confirmed |
| 2026-11-26 | BTAI | Igalmi (dexmedetomidine sublingual film) | BioXcel Therapeutics | CNS | confirmed |
| 2026-11-27 | N/A | Saroglitazar | Zydus Therapeutics | Liver Disease | confirmed |
| 2026-11-27 | GSK | Neladalkib (NVL-655) | Nuvalent (acquired by GlaxoSmithKline) | Cancer | confirmed |
| 2026-11-27 | BBIO | BBP-418 (ribitol) | BridgeBio | CNS, Musculoskeletal | confirmed |
| 2026-11-30est | JNJ | Rybrevant Faspro (amivantamab SC) | Johnson & Johnson (Janssen) | Cancer | estimated |
| 2026-11-30 | VRTX | Povetacicept | Vertex | Renal Disease | confirmed |
| 2026-11-30 | RHHBY | Giredestrant (RG6171, GDC-9545) | Genentech (Roche) | Cancer | estimated |
| 2026-11-30 | COGT | Bezuclastinib | Cogent Biosciences | Cancer | estimated |
| 2026-12-03est | ABBV | Rinvoq (upadacitinib) | AbbVie | Dermatology, Immunology | estimated |
| 2026-12-03 | EXEL | Zanzalintinib | Exelixis | Cancer | estimated |
| 2026-12-04 | RHHBY | Gazyva (obinutuzumab) | Genentech (Roche) / Biogen | Renal, Immunology | confirmed |
| 2026-12-12 | VNDA | Imsidolimab | Vanda Pharmaceuticals / AnaptysBio | Dermatology, Immunology | confirmed |
| 2026-12-15est | N/A | Anzupgo (delgocitinib) | LEO Pharma / Japan Tobacco | Dermatology | estimated |
| 2026-12-18 | N/A | CAM2029 (octreotide SC depot) | Camurus | Endocrine | estimated |
| 2026-12-18est | NVS | Rhapsido (remibrutinib) | Novartis | Dermatology, Immunology | estimated |
| 2026-12-18est | NVO | CagriSema (cagrilintide + semaglutide) | Novo Nordisk | Metabolic | estimated |
| 2026-12-18 | N/A | Tirabrutinib | Deciphera (Ono Pharmaceutical) | Cancer | confirmed |
| 2026-12-18 | RHHBY | Giredestrant (RG6171, GDC-9545) | Genentech (Roche) | Cancer | estimated |
| 2026-12-19 | HNSA | Imlifidase (Idefirix in EU) | Hansa Biopharma | Immunology | confirmed |
| 2026-12-20est | RDY | DRL_AB (abatacept biosimilar) | Dr Reddy's | Immunology | estimated |
| 2026-12-23 | GILD | Anitocabtagene autoleucel (anito-cel) | Arcellx (acquired by Gilead) | Cancer | estimated |
| 2026-12-26 | MLYS | Lorundrostat | Mineralys | Cardiovascular | confirmed |
| 2026-12-27 | VTRS | MR-107A-02 (fast-acting meloxicam) | Viatris | CNS | estimated |
| 2026-12-27 | PRAX | Relutrigine (PRAX-562) | Praxis Precision Medicines | CNS | confirmed |
| 2026-12-29est | IMNM | Varegacestat (AL102) | Immunome | Cancer | estimated |
| 2026-12-30 | N/A | SL1009 (sodium dichloroacetate oral soln) | Saol Therapeutics | Inborn Errors | estimated |
| 2026-12-30 | COGT | Bezuclastinib | Cogent Biosciences | Blood Disorders | estimated |
| 2026-12-31est | N/A | Lorecivivint (SM04690) | Biosplice Therapeutics | Bone, CNS | estimated |
| 2027-01-01est | PYPD | D-PLEX100 (doxycycline CR) | PolyPid | Infectious Disease | estimated |
| 2027-01-04 | NUVB | Ibtrozi (taletrectinib) | Nuvation Bio (AnHeart) | Cancer | estimated |
| 2027-01-06 | IBRX | Anktiva (nogapendekin alfa inbakicept) | ImmunityBio (Altor BioScience) | Cancer | estimated |
| 2027-01-09 | N/A | Tegoprazan | Sebela Pharmaceuticals (Braintree) | Gastrointestinal | estimated |
| 2027-01-14est | AZN | Zegfrovy (sunvozertinib) | AstraZeneca / Dizal | Cancer | estimated |
| 2027-01-21 | DYN | Zeleciment rostudirsen (DYNE-251) | Dyne Therapeutics | CNS | confirmed |
| 2027-01-22est | RVMD | Daraxonrasib (RMC-6236) | Revolution Medicines | Cancer | estimated |
| 2027-01-28est | NVS | Cosentyx (secukinumab) | Novartis | Immunology | estimated |
| 2027-01-28 | ZBIO | Obexelimab | Zenas BioPharma | Immunology | estimated |
| 2027-01-29 | PRAX | Ulixacaltamide | Praxis Precision Medicines | CNS | estimated |
| 2027-01-30est | TEVA | Omalizumab biosimilar | Teva | Immunology, Respiratory | estimated |
| 2027-01-31 | N/A | Cenobamate oral suspension | SK Life Science | CNS | confirmed |
| 2027-02-09est | TAK | Entyvio (vedolizumab) | Takeda | Gastrointestinal | confirmed |
| 2027-02-09 | RHHBY | Lunsumio Velo (mosunetuzumab SC) | Genentech (Roche) | Cancer | confirmed |
| 2027-02-12 | BLTE | Tinlarebant (LBS-008) | Belite Bio | Ophthalmology | estimated |
| 2027-02-23 | N/A | Fetroja (cefiderocol) | Shionogi | Infectious Disease | confirmed |
| 2027-02-23 | ARQT | Zoryve (roflumilast cream) | Arcutis Biotherapeutics | Dermatology, Immunology | confirmed |
| 2027-02-25est | NVS | Delpacibart zotadirsen (AOC 1044) | Novartis (Avidity Biosciences) | CNS | estimated |
| 2027-02-28 | N/A | AD109 (aroxybutynin + atomoxetine) | Apnimed | CNS | confirmed |
| 2027-02-28 | SRPT | Amondys 45 (casimersen) | Sarepta | CNS | estimated |
| 2027-02-28 | SRPT | Vyondys 53 (golodirsen) | Sarepta | CNS | estimated |
| 2027-03-11 | BMY | Reblozyl (luspatercept-aamt) | Bristol Myers Squibb / Merck | Blood Disorders | estimated |
| 2027-03-22 | MRK | Enflonsia (clesrovimab-cfor) | Merck | Infectious Disease | estimated |
| 2027-03-29est | JNJ | Tecvayli (teclistamab-cqyv) | Johnson & Johnson (Janssen) | Cancer | estimated |
| 2027-04-08est | TEVA | AVT16 (vedolizumab biosimilar) | Alvotech / Teva | Gastrointestinal | confirmed |
| 2027-04-13est | JNJ | Talvey (talquetamab-tgvs) | Johnson & Johnson (Janssen) | Cancer | estimated |
| 2027-04-14 | INBX | Ozekibart (INBRX-109) | Inhibrx | Cancer | estimated |
| 2027-04-17est | N/A | Isoflurane (Sedaconda in EU) | Sedana Medical | CNS | estimated |
| 2027-04-23 | PHVS | Deucrictibant immediate-release capsule | Pharvaris | Blood Disorders | estimated |
| 2027-04-24 | ORGO | Amnuvx (azimplacel, known as ReNu) | Organogenesis (NuTech Medical) | CNS, Bone | confirmed |
| 2027-05-01 | AXSM | AXS-12 (reboxetine) | Axsome Therapeutics | CNS | confirmed |
| 2027-05-08 | BBIO | Encaleret | BridgeBio | Endocrine | confirmed |
| 2027-05-13 | BMY | Mezigdomide | Bristol Myers Squibb | Cancer | confirmed |
| 2027-06-24est | N/A | Disaggpro (zalunfiban) | CeleCor | Cardiovascular | estimated |
| 2027-06-28est | TEVA | Ecopipam | Teva | CNS | estimated |
No canonical source exists. The FDA does not publish a forward-looking calendar of pending user fee goal dates; confidentiality rules bar it from confirming an application exists until the sponsor discloses it. Every calendar of this kind aggregates company announcements and securities filings.
Method. Regulatory trackers are cross-checked against each other and then against the sponsor's own securities filings. Trackers share upstream sources and therefore tend to be wrong together, so filing-level confirmation is treated as the deciding evidence rather than tracker consensus.
Confidence. Confirmed — the goal date is corroborated by a primary filing. Estimated — the date is month-level or an 'or earlier' ceiling rather than a published day, or filing confirmation was unavailable. Estimated dates are marked inline and should not be treated as fixed.
Coverage limit. Filing-level confirmation reaches SEC registrants only. Sponsors that are private or not US-listed return no filings, and those rows rest on tracker data alone. Absence of a filing is never evidence that a review has closed. This run: 48 of 83 rows carry a primary filing reference; 31 sponsors are not SEC registrants.
Provided for informational purposes. Not investment advice and not a recommendation regarding any security.