Regulatory timeline
60 dated events across 23 products, including 49 approvals, plus designations, filings, complete response letters, withdrawals, and label changes. Sort by date, filter by type or region, and click through to the product. The FDA approvals feed below is refreshed weekly and shows what is new since the last build and what is not yet in the corpus.
FDA approvals feed
fetched 2026-10-21, previous 2026-10-1428 approvals and supplements for corpus products from Drugs@FDA since 2026-06-23; 28 new since the last snapshot. 18 are not yet recorded as regulatory events on the product page.
- 2026-10-16KEYTRUDA QLEX (PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH): Efficacynewnot on product pagePembrolizumab
- 2026-10-16KEYTRUDA (PEMBROLIZUMAB): Efficacynewnot on product pagePembrolizumab
- 2026-09-29RIABNI (RITUXIMAB-ARRX): Bioequivalencenewnot on product pageRituximab
- 2026-09-28RUXIENCE (RITUXIMAB-PVVR): SUPPLnewnot on product pageRituximab
- 2026-09-25CAPECITABINE (CAPECITABINE): Labelingnewnot on product pageCapecitabine
- 2026-09-21EVEROLIMUS (EVEROLIMUS): ORIGnewnot on product pageEverolimus
- 2026-09-16ZORTRESS (EVEROLIMUS): Labelingnewnot on product pageEverolimus
- 2026-09-14BEXLUTRY (LUTETIUM LU-177 DOTATATE): Type 5 - New Formulation or New ManufacturernewLutetium-177 dotatate (radioligand equivalent)
- 2026-09-11PIXCLARA (FLORETYROSINE F-18): Type 1 - New Molecular EntitynewFloretyrosine F-18 (FET)
- 2026-09-03OMCAZIO (CABOZANTINIB LAURYLSULFATE): Type 5 - New Formulation or New Manufacturernewnot on product pageCabozantinib
- 2026-08-31FLUDEOXYGLUCOSE F18 (FLUDEOXYGLUCOSE F 18): Manufacturing (CMC)newnot on product pageFludeoxyglucose F-18 (FDG)Fludeoxyglucose F-18 (brain metabolism)
- 2026-08-31IMFINZI (DURVALUMAB): Labelingnewnot on product pageDurvalumab
Not yet in the corpus
Label and efficacy supplements (openFDA)
28 approved submissions for corpus products since 2026-06-23, from openFDA drugsfda. Efficacy and labelling supplements are listed; manufacturing and REMS changes are not.
- 2026-10-16PembrolizumabEfficacy · BLA761467
- 2026-10-16PembrolizumabEfficacy · BLA125514
- 2026-09-25CapecitabineLabeling · ANDA090943
- 2026-09-16EverolimusLabeling · NDA021560
- 2026-08-31DurvalumabLabeling · BLA761069
- 2026-07-31Lutetium-177 vipivotide tetraxetanEfficacy · NDA215833
- 2026-07-31PembrolizumabLabeling · BLA761467
- 2026-07-24EnzalutamideEfficacy · NDA203415
- 2026-07-24EnzalutamideEfficacy · NDA213674
- 2026-07-22Florbetaben F-18Labeling · NDA204677
60 events
| Event | Region | What happened | ||
|---|---|---|---|---|
| 14 Sept 2026 | Approval | US | Bexlutry, NDA 218525 (Curium), original approval; FDA classification Type 5 new formulation or new manufacturer, standard review source | |
| 11 Sept 2026 | Approval | US | Pixclara, NDA 218592 (Telix Pharmaceuticals US), original approval; FDA classification Type 1 new molecular entity source | |
| 28 Aug 2026 | 177Lu-edotreotide Radioligand therapy (beta) | PDUFA date | US | PDUFA goal date for GEP-NET indication source |
| 13 Aug 2026 | Approval | US | Tauklarify, NDA 220496 (Cerveau/Lantheus), original approval; FDA classification Type 1 new molecular entity, standard review source | |
| 31 Jul 2026 | Approval | US | PSMA+ metastatic hormone-sensitive prostate cancer with ARPI (PSMAddition) source | |
| 24 Jul 2026 | Label change | US | US Prescribing Information updated with overall survival data from EMBARK (NDA 203415/S-026, NDA 213674/S-016; efficacy labelling change with clinical data) source | |
| 10 Jul 2026 | Approval | US | Muscle-invasive bladder cancer with enfortumab vedotin, as pembrolizumab or pembrolizumab with berahyaluronidase alfa source | |
| 24 Jun 2026 | Approval | US | First-line PD-L1+ TNBC with sacituzumab govitecan (ASCENT-04) source | |
| 12 Jun 2026 | Approval | US | Adjuvant RCC with belzutifan (LITESPARK-022) source | |
| 8 Jun 2026 | Gallium-68 gozetotide (PSMA-11) PET imaging agent | Approval | US | Gallium Ga 68 gozetotide from RadioMedix approved under an abbreviated new drug application, ANDA 216410 (original approval) source |
| 28 May 2026 | Approval | US | High-risk non-muscle-invasive bladder cancer with BCG (POTOMAC) source | |
| 30 Apr 2026 | Florastamin F-18 PSMA-targeted PET radiotracer, fluorine-18 | Approval | South Korea | MFDS marketing approval as Korea's 43rd domestically developed new drug source |
| 2 Apr 2026 | Technetium (99mTc) pexiretide Integrin αvβ3-targeted SPECT imaging agent (RGD peptide dimer) | Approval | China | NMPA marketing approval (priority review), trade name Jilunte source |
| 9 Mar 2026 | Piflufolastat F-18 / Pylarify TruVu PET imaging agent | Approval | US | Pylarify TruVu formulation source |
| Q1 2026 | Approval | US | Platinum-resistant PD-L1+ ovarian cancer source | |
| Nov 2025 | Approval | US | Perioperative gastric/GEJ cancer with FLOT (MATTERHORN) source | |
| Sept 2025 | Approval | US | Subcutaneous pembrolizumab (Keytruda Qlex) source | |
| 28 Mar 2025 | Approval | US | Perioperative muscle-invasive bladder cancer (NIAGARA) source | |
| 28 Mar 2025 | Approval | US | PSMA+ mCRPC after ARPI, before chemotherapy (PSMAfore) source | |
| 26 Mar 2025 | Approval | US | NET indication on CABINET source | |
| Mar 2025 | 177Lu-edotreotide Radioligand therapy (beta) | Designation | US | COMPETE topline at ENETS 2025 source |
| Feb 2025 | Technetium (99mTc) pexiretide Integrin αvβ3-targeted SPECT imaging agent (RGD peptide dimer) | Withdrawal | China | An earlier new drug application for the same product was withdrawn before being resubmitted; reported by Chinese trade press, not by the regulator source |
| 4 Dec 2024 | Approval | US | Limited-stage SCLC after chemoradiation (ADRIATIC) source | |
| 27 Sept 2024 | Flurpiridaz F-18 PET tracer | Approval | US | FDA approved Flyrcado (flurpiridaz F 18) injection, NDA 215168, for PET myocardial perfusion imaging under rest or stress (pharmacologic or exercise) in adults with known or suspected CAD. source |
| Jun 2024 | Actinium-225 PSMA agents Targeted alpha therapy | Filing / deal | US | AstraZeneca completes Fusion Pharmaceuticals acquisition; FPI-2265 phase 3 planned source |
| Jun 2024 | Lutetium-177 dotatate Radioligand therapy (beta) | Label change | US | First-line label based on NETTER-2 source |
| 23 Apr 2024 | Lutetium-177 dotatate Radioligand therapy (beta) | Approval | US | Paediatric patients ≥12 years source |
| 26 Feb 2024 | Actinium-225 DOTATATE Targeted alpha therapy | Filing / deal | US | BMS completes RayzeBio acquisition ($4.1B) source |
| 16 Oct 2023 | Approval | US | Perioperative NSCLC (KEYNOTE-671) source | |
| 29 Sept 2023 | Technegas (technetium Tc-99m labelled carbon inhalation aerosol) Inhaled SPECT/gamma camera aerosol | Approval | US | FDA approval of NDA 022335 (Cyclomedica Australia), Type 3 new dosage form source |
| 31 May 2023 | Olaparib Small-molecule PARP inhibitor | Approval | US | With abiraterone in BRCA-mutated mCRPC (PROpel) source |
| Jan 2023 | FAP-2286 (177Lu / 68Ga) Theranostic pair (peptide radioligand) | Filing / deal | US | Novartis acquires rights after Clovis bankruptcy source |
| Dec 2022 | Approval | EU | EMA approval source | |
| 21 Oct 2022 | Approval | US | HCC with tremelimumab (HIMALAYA) source | |
| 2 Sept 2022 | Approval | US | Biliary tract cancer with chemotherapy (TOPAZ-1) source | |
| 23 Mar 2022 | Approval | US | PSMA+ mCRPC after ARPI and taxane (VISION) source | |
| 11 Mar 2022 | Olaparib Small-molecule PARP inhibitor | Approval | US | Adjuvant gBRCA high-risk HER2-negative early breast cancer (OlympiA) source |
| 26 Jul 2021 | Approval | US | High-risk early TNBC, neoadjuvant and adjuvant (KEYNOTE-522) source | |
| Jun 2021 | Designation | US | Breakthrough Therapy designation source | |
| 26 May 2021 | Piflufolastat F-18 / Pylarify TruVu PET imaging agent | Approval | US | PSMA PET imaging in prostate cancer: first 18F PSMA agent source |
| 13 Nov 2020 | Approval | US | Metastatic TNBC, PD-L1 CPS ≥10, with chemotherapy (KEYNOTE-355) source | |
| 16 Jun 2020 | Approval | US | TMB-high solid tumours (tumour-agnostic) source | |
| 19 May 2020 | Olaparib Small-molecule PARP inhibitor | Approval | US | HRR-mutant mCRPC (PROfound) source |
| 27 Mar 2020 | Approval | US | Extensive-stage SCLC with chemotherapy (CASPIAN) source | |
| 27 Dec 2019 | Olaparib Small-molecule PARP inhibitor | Approval | US | gBRCA metastatic pancreatic cancer maintenance (POLO) source |
| 19 Dec 2018 | Olaparib Small-molecule PARP inhibitor | Approval | US | First-line maintenance in BRCA-mutated ovarian cancer (SOLO-1) source |
| 16 Feb 2018 | Approval | US | Unresectable stage III NSCLC after chemoradiation (PACIFIC) source | |
| 26 Jan 2018 | Lutetium-177 dotatate Radioligand therapy (beta) | Approval | US | SSTR+ gastroenteropancreatic NETs (NETTER-1) source |
| 12 Jan 2018 | Olaparib Small-molecule PARP inhibitor | Approval | US | gBRCA HER2-negative metastatic breast cancer (OlympiAD) source |
| 26 Sept 2017 | Lutetium-177 dotatate Radioligand therapy (beta) | Approval | EU | EMA approval: first modern PRRT source |
| 17 Aug 2017 | Olaparib Small-molecule PARP inhibitor | Approval | US | Maintenance in platinum-sensitive recurrent ovarian cancer; tablet formulation source |
| 23 May 2017 | Approval | US | MSI-H/dMMR solid tumours: first tumour-agnostic approval source | |
| 1 May 2017 | Approval | US | Urothelial carcinoma (accelerated; later withdrawn 2021) source | |
| 2 Oct 2015 | Approval | US | PD-L1+ NSCLC after platinum source | |
| 19 Dec 2014 | Olaparib Small-molecule PARP inhibitor | Approval | US | gBRCA advanced ovarian cancer after ≥3 lines: first PARP inhibitor source |
| 4 Sept 2014 | Approval | US | Accelerated approval, advanced melanoma after ipilimumab; first PD-1 inhibitor in the US source | |
| 20 Feb 2014 | Iodine-131 tositumomab radioimmunotherapy | Withdrawal | US/CA | Marketing of the Bexxar therapeutic regimen formally discontinued. source |
| 6 Aug 2013 | Iodine-131 tositumomab radioimmunotherapy | Withdrawal | US/CA | GlaxoSmithKline announced it would discontinue manufacture and sale of the Bexxar regimen, citing declining use (about 75 US patients in 2012) and available alternative therapies. source |
| 16 Nov 2007 | Sorafenib Small-molecule multi-kinase inhibitor (VEGFR, PDGFR, RAF) | Approval | US | Unresectable HCC on SHARP |
| 1946 | Radioactive iodine (I-131) Radiopharmaceutical (beta/gamma emitter, natural uptake) | Approval | US | First therapeutic use in thyroid cancer (Seidlin); formal approval followed |
Feed status and refresh schedule: data currency. Events on product pages are hand-sourced; the feed is a prompt to add them, not a replacement.