{"fetched":"2026-09-09","window":{"from":"2026-05-12","to":"2026-09-09"},"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":"2026-09-09","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":[],"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-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":[],"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":["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":["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"],"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":[],"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-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"],"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":"2026-06-24","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"],"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-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"],"cancerIds":["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"],"firstSeen":"2026-09-09"},{"date":"2026-05-28","title":"FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder","summary":"On May 28, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).","drugIds":["durvalumab"],"cancerIds":["urothelial"],"firstSeen":"2026-09-09"},{"date":"2026-05-27","title":"FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare","summary":"On May 27, 2026, the Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).","drugIds":["pivekimab-sunirine"],"cancerIds":["bpdcn"],"firstSeen":"2026-09-09"},{"date":"2026-05-22","title":"FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer","summary":"On May 22, 2026, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.","drugIds":["datopotamab-deruxtecan"],"cancerIds":["tnbc"],"firstSeen":"2026-09-09"},{"date":"2026-05-15","title":"FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage","summary":"On May 15, 2026, the Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo, Inc.) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for T-DXd followed by a taxane, trastuzumab, and pertuzumab (THP), for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test. The second indication is for T-DXd for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (with or without pertuzumab) and taxane-based treatment.","drugIds":["trastuzumab-deruxtecan","trastuzumab","pertuzumab"],"cancerIds":[],"firstSeen":"2026-09-09"},{"date":"2026-05-15","title":"FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-adjuvant-treatment-muscle-invasive-bladder-cancer-patients-molecular","summary":"On May 15, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc. and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test.","drugIds":["atezolizumab"],"cancerIds":["urothelial"],"firstSeen":"2026-09-09"},{"date":"2026-05-13","title":"FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute","summary":"On May 13, 2026, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.","drugIds":["decitabine-cedazuridine","venetoclax"],"cancerIds":[],"firstSeen":"2026-09-09"},{"date":"2026-05-13","title":"FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma","summary":"On May 13, 2026, the Food and Drug Administration granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.","drugIds":["sonrotoclax"],"cancerIds":["mantle-cell-lymphoma"],"firstSeen":"2026-09-09"}],"drugsfda":[{"applicationNumber":"NDA020785","sponsor":"BRISTOL-MYERS","brand":"THALOMID","generic":"THALIDOMIDE","submissionType":"SUPPL","submissionNumber":"74","classCode":"REMS","classDescription":"REMS","statusDate":"2026-09-02","drugIds":["thalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA213267","sponsor":"NATCO","brand":"THALIDOMIDE","generic":"THALIDOMIDE","submissionType":"SUPPL","submissionNumber":"2","classCode":"REMS","classDescription":"REMS","statusDate":"2026-09-02","drugIds":["thalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA020457","sponsor":"CHEPLAPHARM","brand":"ETOPOPHOS PRESERVATIVE FREE","generic":"ETOPOSIDE PHOSPHATE","submissionType":"SUPPL","submissionNumber":"20","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-02","drugIds":["platinum-etoposide","etoposide"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA216340","sponsor":"BRISTOL","brand":"KRAZATI","generic":"ADAGRASIB","submissionType":"SUPPL","submissionNumber":"11","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-01","drugIds":["adagrasib"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761289","sponsor":"ASTRAZENECA AB","brand":"IMJUDO","generic":"TREMELIMUMAB","submissionType":"SUPPL","submissionNumber":"9","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["tremelimumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA219718","sponsor":"CIPLA","brand":"POMALIDOMIDE","generic":"POMALIDOMIDE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-08-31","drugIds":["pomalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761297","sponsor":"CHECKPOINT THERAPEUTICS INC","brand":"UNLOXCYT","generic":"COSIBELIMAB","submissionType":"SUPPL","submissionNumber":"4","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["cosibelimab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA213234","sponsor":"DR REDDYS","brand":"POMALIDOMIDE","generic":"POMALIDOMIDE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-08-31","drugIds":["pomalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761049","sponsor":"EMD SERONO INC","brand":"BAVENCIO","generic":"AVELUMAB","submissionType":"SUPPL","submissionNumber":"26","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["avelumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761069","sponsor":"ASTRAZENECA UK LTD","brand":"IMFINZI","generic":"DURVALUMAB","submissionType":"SUPPL","submissionNumber":"60","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["durvalumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA210232","sponsor":"SPIL","brand":"POMALIDOMIDE","generic":"POMALIDOMIDE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-08-31","drugIds":["pomalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761097","sponsor":"REGENERON PHARMACEUTICALS","brand":"LIBTAYO","generic":"CEMIPLIMAB-RWLC","submissionType":"SUPPL","submissionNumber":"38","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["cemiplimab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA220741","sponsor":"SANDOZ","brand":"POMALIDOMIDE","generic":"POMALIDOMIDE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-08-31","drugIds":["pomalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA125377","sponsor":"BRISTOL MYERS SQUIBB","brand":"YERVOY","generic":"IPILIMUMAB","submissionType":"SUPPL","submissionNumber":"140","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["ipilimumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761240","sponsor":"COHERUS BIOSCIENCES INC","brand":"LOQTORZI","generic":"TORIPALIMAB-TPZI","submissionType":"SUPPL","submissionNumber":"6","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["toripalimab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761258","sponsor":"AKESO BIOPHARMA","brand":"PENPULIMAB-KCQX","generic":"PENPULIMAB","submissionType":"SUPPL","submissionNumber":"2","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["penpulimab"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA220605","sponsor":"TAKEDA PHARMACEUTICALS U.S.A., INC.","brand":"MIMRYLO","generic":"RUSFERTIDE","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 1","classDescription":"Type 1 - New Molecular Entity","statusDate":"2026-08-28","drugIds":["rusfertide"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761166","sponsor":"PHARMAESSENTIA CORP","brand":"BESREMI","generic":"ROPEGINTERFERON ALFA-2B","submissionType":"SUPPL","submissionNumber":"13","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-08-28","drugIds":["ropeginterferon-alfa-2b"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA213225","sponsor":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","brand":"VOBRIG","generic":"LEUPROLIDE ACETATE","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 5","classDescription":"Type 5 - New Formulation or New Manufacturer","statusDate":"2026-08-26","drugIds":["goserelin"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA220910","sponsor":"REVOLUTION MEDICINES INC","brand":"RASONQUE","generic":"DARAXONRASIB","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 1","classDescription":"Type 1 - New Molecular Entity","statusDate":"2026-08-26","drugIds":["daraxonrasib"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761416","sponsor":"JAZZ 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