{"fetched":"2026-09-30","previousFetched":"2026-09-23","window":{"from":"2026-06-02","to":"2026-09-30"},"sources":{"oce":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","drugsfda":"https://api.fda.gov/drug/drugsfda.json"},"oce":[{"date":"2026-09-24","title":"FDA approves belzutifan in combination with lenvatinib for advanced renal cell carcinoma with a clear cell component","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-combination-lenvatinib-advanced-renal-cell-carcinoma-clear-cell-component","summary":"On September 24, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with lenvatinib (Lenvima, Eisai Inc.) for adults with advanced renal cell carcinoma with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.","drugIds":["lenvatinib","belzutifan"],"cancerIds":["rcc","clear-cell-rcc"],"firstSeen":"2026-09-30"},{"date":"2026-09-23","title":"FDA approves lirafugratinib for previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lirafugratinib-previously-treated-unresectable-locally-advanced-or-metastatic","summary":"On September 23, 2026, the Food and Drug Administration approved lirafugratinib (Lyrfigtu, Elevar Therapeutics, Inc.), a kinase inhibitor, for the treatment of adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement.","drugIds":["lirafugratinib"],"cancerIds":[],"firstSeen":"2026-09-30"},{"date":"2026-09-18","title":"FDA approves imlunestrant in combination with abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-combination-abemaciclib-er-positive-her2-negative-esr1-mutated-advanced-or","summary":"On September 18, 2026, the Food and Drug Administration approved imlunestrant (Inluriyo) in combination with abemaciclib (Verzenio), for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. Inluriyo and Verzenio are manufactured by Eli Lilly and Company.","drugIds":["imlunestrant","abemaciclib"],"cancerIds":["breast-hr-positive","breast-cancer"],"firstSeen":"2026-09-23"},{"date":"2026-09-09","title":"FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small","summary":"On September 9, 2026, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.","drugIds":["sevabertinib"],"cancerIds":["lung-cancer","lung-squamous-cell-carcinoma","nsclc"],"firstSeen":"2026-09-09"},{"date":"2026-09-04","title":"FDA grants accelerated approval to camizestrant with a CDK4/6 inhibitor for ESR1-Mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negative","summary":"On September 4, 2026, the Food and Drug Administration granted accelerated approval to camizestrant (Etcamah, AstraZeneca), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.","drugIds":["camizestrant","palbociclib","abemaciclib","ribociclib"],"cancerIds":["breast-cancer","breast-hr-positive"],"firstSeen":"2026-09-09"},{"date":"2026-08-26","title":"FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma","summary":"On August 26, 2026, the Food and Drug Administration approved daraxonrasib (RASONQUE, Revolution Medicines, Inc.), an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.","drugIds":["daraxonrasib"],"cancerIds":["pancreatic","urethral-adenocarcinoma","lung-adenocarcinoma"],"firstSeen":"2026-09-09"},{"date":"2026-08-25","title":"FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction","summary":"On August 25, 2026, the Food and Drug Administration approved zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals) in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr (Tevimbra, BeOne Medicines USA, Inc.), as first-line treatment for adults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test, and in combination with fluoropyrimidine-, and platinum-containing chemotherapy, as first-line treatment for adults with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test.: dolutegravir","drugIds":["tislelizumab","zanidatamab","platinum-etoposide"],"cancerIds":["oesophageal-adenocarcinoma","urethral-adenocarcinoma","lung-adenocarcinoma","gastric"],"firstSeen":"2026-09-09"},{"date":"2026-08-13","title":"FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone","summary":"On August 13, 2026, the Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol-Myers Squibb Company) 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.","drugIds":["dexamethasone","daratumumab","iberdomide"],"cancerIds":["multiple-myeloma"],"firstSeen":"2026-09-09"},{"date":"2026-08-06","title":"FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma","summary":"On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.","drugIds":["vusolimogene-oderparepvec","nivolumab","relatlimab-nivolumab"],"cancerIds":["melanoma"],"firstSeen":"2026-09-09"},{"date":"2026-07-31","title":"FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-androgen-receptor-pathway-inhibitor-therapy","summary":"On July 31, 2026, the Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or-sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer).","drugIds":["pluvicto"],"cancerIds":["prostate-mhspc","prostate"],"firstSeen":"2026-09-09"},{"date":"2026-07-22","title":"FDA approves zidesamtinib for ROS1 -positive non-small cell lung cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer","summary":"On July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI).","drugIds":["zidesamtinib"],"cancerIds":["lung-cancer","nsclc"],"firstSeen":"2026-09-09"},{"date":"2026-07-14","title":"FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally","summary":"On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.","drugIds":["fulvestrant","palbociclib","gedatolisib"],"cancerIds":["breast-cancer","breast-hr-positive"],"firstSeen":"2026-09-09"},{"date":"2026-07-14","title":"FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive","summary":"On July 14, 2026, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.","drugIds":["selpercatinib"],"cancerIds":[],"firstSeen":"2026-09-09"},{"date":"2026-07-10","title":"FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin","summary":"On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC). This extends the prior approval for the regimen in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy.","drugIds":["enfortumab-vedotin","pembrolizumab","gemcitabine-cisplatin","cisplatin"],"cancerIds":["urothelial","muscle-invasive-bladder-cancer"],"firstSeen":"2026-09-09"},{"date":"2026-07-09","title":"FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications","summary":"On July 9, 2026, the Food and Drug Administration approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma indications.","drugIds":["isatuximab"],"cancerIds":["multiple-myeloma"],"firstSeen":"2026-09-09"},{"date":"2026-06-30","title":"FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-allogeneic-regulatory-t-cell-based-immunotherapy-hspc-and-t-cells-vldq-use-matched","summary":"On June 30, 2026, the Food and Drug Administration approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell (HSPC) and T cells-vldq (Tregzi, Orca Bio) for use in matched donor hematopoietic stem cell transplantation (HSCT) with a myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGHVD)-free survival, in the treatment of adults with hematological malignancies.","drugIds":["tregzi"],"cancerIds":[],"firstSeen":"2026-09-23"},{"date":"2026-06-24","title":"FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line","summary":"On June 24, 2026, the Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two indications in adults with triple-negative breast cancer (TNBC).","drugIds":["sacituzumab-govitecan","pembrolizumab"],"cancerIds":["tnbc","breast-cancer"],"firstSeen":"2026-09-09"},{"date":"2026-06-24","title":"FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance","summary":"On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.","drugIds":["palbociclib","trastuzumab","pertuzumab"],"cancerIds":["breast-cancer","breast-hr-positive"],"firstSeen":"2026-09-09"},{"date":"2026-06-12","title":"FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation","summary":"On June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test.","drugIds":["capivasertib","abiraterone","prednisone"],"cancerIds":["prostate-mhspc","prostate"],"firstSeen":"2026-09-09"},{"date":"2026-06-12","title":"FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma","summary":"On June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.","drugIds":["pembrolizumab","belzutifan"],"cancerIds":["rcc","clear-cell-rcc"],"firstSeen":"2026-09-09"}],"drugsfda":[{"applicationNumber":"BLA125486","sponsor":"GENENTECH","brand":"GAZYVA","generic":"OBINUTUZUMAB","submissionType":"SUPPL","submissionNumber":"43","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-09-25","drugIds":["obinutuzumab"],"firstSeen":"2026-09-30"},{"applicationNumber":"NDA206947","sponsor":"EISAI INC","brand":"LENVIMA","generic":"LENVATINIB","submissionType":"SUPPL","submissionNumber":"35","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-09-24","drugIds":["lenvatinib"],"firstSeen":"2026-09-30"},{"applicationNumber":"NDA215383","sponsor":"MERCK SHARP DOHME","brand":"WELIREG","generic":"BELZUTIFAN","submissionType":"SUPPL","submissionNumber":"17","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-24","drugIds":["belzutifan"],"firstSeen":"2026-09-30"},{"applicationNumber":"NDA215383","sponsor":"MERCK SHARP DOHME","brand":"WELIREG","generic":"BELZUTIFAN","submissionType":"SUPPL","submissionNumber":"13","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-09-24","drugIds":["belzutifan"],"firstSeen":"2026-09-30"},{"applicationNumber":"NDA220425","sponsor":"ELEVAR THERAPEUTICS INC","brand":"LYRFIGTU","generic":"LIRAFUGRATINIB HYDROCHLORIDE","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 1","classDescription":"Type 1 - New Molecular Entity","statusDate":"2026-09-23","drugIds":["lirafugratinib"],"firstSeen":"2026-09-30"},{"applicationNumber":"NDA212099","sponsor":"BAYER HEALTHCARE","brand":"NUBEQA","generic":"DAROLUTAMIDE","submissionType":"SUPPL","submissionNumber":"16","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-22","drugIds":["darolutamide"],"firstSeen":"2026-09-30"},{"applicationNumber":"NDA215358","sponsor":"NOVARTIS","brand":"SCEMBLIX","generic":"ASCIMINIB HYDROCHLORIDE","submissionType":"SUPPL","submissionNumber":"15","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-22","drugIds":["asciminib"],"firstSeen":"2026-09-30"},{"applicationNumber":"ANDA206801","sponsor":"FRESENIUS KABI USA","brand":"PALONOSETRON HYDROCHLORIDE","generic":"PALONOSETRON","submissionType":"SUPPL","submissionNumber":"2","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-21","drugIds":["palonosetron"],"firstSeen":"2026-09-30"},{"applicationNumber":"ANDA206802","sponsor":"FRESENIUS KABI USA","brand":"PALONOSETRON HYDROCHLORIDE","generic":"PALONOSETRON","submissionType":"SUPPL","submissionNumber":"2","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-21","drugIds":["palonosetron"],"firstSeen":"2026-09-30"},{"applicationNumber":"ANDA220597","sponsor":"NOVITIUM PHARMA","brand":"EVEROLIMUS","generic":"EVEROLIMUS","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-09-21","drugIds":["everolimus"],"firstSeen":"2026-09-30"},{"applicationNumber":"ANDA218217","sponsor":"AMNEAL","brand":"LANREOTIDE ACETATE","generic":"LANREOTIDE ACETATE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-09-18","drugIds":["octreotide-lanreotide"],"firstSeen":"2026-09-30"},{"applicationNumber":"NDA208716","sponsor":"ELI LILLY AND CO","brand":"VERZENIO","generic":"ABEMACICLIB","submissionType":"SUPPL","submissionNumber":"22","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-09-18","drugIds":["abemaciclib"],"firstSeen":"2026-09-30"},{"applicationNumber":"NDA218881","sponsor":"ELI LILLY AND CO","brand":"INLURIYO","generic":"IMLUNESTRANT","submissionType":"SUPPL","submissionNumber":"1","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-09-18","drugIds":["imlunestrant"],"firstSeen":"2026-09-30"},{"applicationNumber":"ANDA090713","sponsor":"TEVA PHARMS USA","brand":"PALONOSETRON HYDROCHLORIDE","generic":"PALONOSETRON HYDROCHLORIDE","submissionType":"SUPPL","submissionNumber":"3","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-17","drugIds":["palonosetron"],"firstSeen":"2026-09-30"},{"applicationNumber":"ANDA079179","sponsor":"APOTEX","brand":"IMATINIB MESYLATE","generic":"IMATINIB 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ADIPATE","submissionType":"SUPPL","submissionNumber":"4","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-09-16","drugIds":["taletrectinib"],"firstSeen":"2026-09-23"},{"applicationNumber":"NDA021560","sponsor":"NOVARTIS","brand":"ZORTRESS","generic":"EVEROLIMUS","submissionType":"SUPPL","submissionNumber":"34","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-16","drugIds":["everolimus"],"firstSeen":"2026-09-30"},{"applicationNumber":"NDA218197","sponsor":"ASTRAZENECA","brand":"TRUQAP","generic":"CAPIVASERTIB","submissionType":"SUPPL","submissionNumber":"6","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-09-16","drugIds":["capivasertib"],"firstSeen":"2026-09-23"},{"applicationNumber":"ANDA090292","sponsor":"ACTAVIS TOTOWA","brand":"LETROZOLE","generic":"LETROZOLE","submissionType":"SUPPL","submissionNumber":"1","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-15","drugIds":["letrozole"],"firstSeen":"2026-09-23"},{"applicationNumber":"ANDA075945","sponsor":"MYLAN PHARMS INC","brand":"AMNESTEEM","generic":"ISOTRETINOIN","submissionType":"SUPPL","submissionNumber":"45","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-15","drugIds":["isotretinoin"],"firstSeen":"2026-09-23"},{"applicationNumber":"ANDA218560","sponsor":"ZYDUS LIFESCIENCES","brand":"TRETINOIN","generic":"TRETINOIN","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-09-15","drugIds":["tretinoin-atra"],"firstSeen":"2026-09-23"},{"applicationNumber":"NDA208065","sponsor":"ASTRAZENECA","brand":"TAGRISSO","generic":"OSIMERTINIB MESYLATE","submissionType":"SUPPL","submissionNumber":"36","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-14","drugIds":["osimertinib"],"firstSeen":"2026-09-23"},{"applicationNumber":"NDA208065","sponsor":"ASTRAZENECA","brand":"TAGRISSO","generic":"OSIMERTINIB MESYLATE","submissionType":"SUPPL","submissionNumber":"35","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-09-14","drugIds":["osimertinib"],"firstSeen":"2026-09-23"},{"applicationNumber":"ANDA220438","sponsor":"ZYDUS LIFESCIENCES","brand":"LETROZOLE","generic":"LETROZOLE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-09-14","drugIds":["letrozole"],"firstSeen":"2026-09-23"},{"applicationNumber":"BLA761344","sponsor":"AMGEN INC","brand":"IMDELLTRA","generic":"TARLATAMAB-DLLE","submissionType":"SUPPL","submissionNumber":"2","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-11","drugIds":["tarlatamab"],"firstSeen":"2026-09-23"},{"applicationNumber":"ANDA203554","sponsor":"RISING","brand":"PENTOSTATIN","generic":"PENTOSTATIN","submissionType":"SUPPL","submissionNumber":"3","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-11","drugIds":["pentostatin"],"firstSeen":"2026-09-23"},{"applicationNumber":"ANDA075184","sponsor":"TEVA 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