Therapeutics– tag –
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Oncology Drug Approval News Flash: Taletrectinib (Ibtrozi) Approved by FDA for ROS1-Positive NSCLC
【FDA Approval Alert】Nuvation Bio's taletrectinib (Ibtrozi) Approved for ROS1-Positive Non-Small Cell Lung Cancer (June 11, 2025) On June 11, 2025, the U.S. FDA approved taletrectinib (Ibtrozi) for adult patients with locally advanced o... -
Oncology Drug Approval News Flash: Darolutamide (Nubeqa) Approved by FDA for Metastatic Castration-Sensitive Prostate Cancer
【FDA Approval Alert】Bayer's darolutamide (Nubeqa) Approved for Metastatic Castration-Sensitive Prostate Cancer (June 3, 2025) On June 3, 2025, the U.S. FDA approved darolutamide (Nubeqa) for metastatic castration-sensitive prostate can... -
Oncology Drug Approval News Flash: Retifanlimab-dlwr (Zynyz) Approved by FDA for Squamous Cell Carcinoma of the Anal Canal
【FDA Approval Alert】Incyte's retifanlimab-dlwr (Zynyz) Approved for Squamous Cell Carcinoma of the Anal Canal (May 15, 2025) On May 15, 2025, the U.S. FDA approved retifanlimab-dlwr (Zynyz) for adults with inoperable locally recurrent ... -
Oncology Drug Approval News Flash: Telisotuzumab Vedotin-tllv (Emrelis) Receives Accelerated FDA Approval for High c-Met NSCLC
【FDA Approval Alert】AbbVie's telisotuzumab vedotin-tllv (Emrelis) Accelerated Approval for High c-Met Non-Small Cell Lung Cancer (May 14, 2025) On May 14, 2025, the U.S. FDA granted accelerated approval to telisotuzumab vedotin-tllv (E... -
Oncology Drug Approval News Flash: Belzutifan (Welireg) Approved by FDA for Pheochromocytoma and Paraganglioma
【FDA Approval Alert】Merck's belzutifan (Welireg) Approved for Pheochromocytoma and Paraganglioma (May 14, 2025) On May 14, 2025, the U.S. FDA approved belzutifan (Welireg) for patients aged 12 years and older with locally advanced, unr... -
Oncology Drug Approval News Flash: Avutometinib + Defactinib (Avmapki Fakzynja Co-pack) Receives Accelerated FDA Approval for KRAS-Mutated LGSOC
【FDA Approval Alert】Verastem's avutometinib + defactinib Approved for KRAS-Mutated Low-Grade Serous Ovarian Cancer (May 8, 2025) On May 8, 2025, the U.S. FDA granted accelerated approval to avutometinib + defactinib (Avmapki Fakzynja C... -
Oncology Drug Approval News Flash: Penpulimab-kcqx (Akeso) Approved by FDA for Non-Keratinizing Nasopharyngeal Carcinoma
【FDA Approval Alert】Akeso's penpulimab-kcqx Approved for Non-Keratinizing Nasopharyngeal Carcinoma (April 23, 2025) On April 23, 2025, the U.S. FDA approved penpulimab-kcqx (Akeso) for adult patients with recurrent or metastatic non-ke... -
Oncology Drug Approval News Flash: Nivolumab + Ipilimumab (Opdivo + Yervoy) Approved by FDA for Advanced Hepatocellular Carcinoma
【FDA Approval Alert】Bristol Myers Squibb's nivolumab + ipilimumab Approved for Advanced Hepatocellular Carcinoma (April 11, 2025) On April 11, 2025, the U.S. FDA approved nivolumab (Opdivo) plus ipilimumab (Yervoy) as first-line treatm... -
Oncology Drug Approval News Flash: Nivolumab + Ipilimumab (Opdivo + Yervoy) Approved by FDA for MSI-H/dMMR Colorectal Cancer
【FDA Approval Alert】Bristol Myers Squibb's nivolumab + ipilimumab Approved for MSI-H/dMMR Colorectal Cancer (April 8, 2025) On April 8, 2025, the U.S. FDA approved nivolumab (Opdivo) plus ipilimumab (Yervoy) for adults and pediatric pa... -
Oncology Drug Approval News Flash: Durvalumab (Imfinzi) Approved by FDA for Muscle-Invasive Bladder Cancer
【FDA Approval Alert】AstraZeneca's durvalumab (Imfinzi) Approved for Muscle-Invasive Bladder Cancer (March 28, 2025) On March 28, 2025, the U.S. FDA approved durvalumab (Imfinzi) for adult patients with muscle-invasive bladder cancer (M... -
Oncology Drug Approval News Flash: Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) FDA Indication Expansion for Earlier-Line mCRPC
【FDA Approval Alert】Novartis's Pluvicto Indication Expanded for PSMA-Positive mCRPC (March 28, 2025) On March 28, 2025, the U.S. FDA expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto) to include adults with PS... -
Oncology Drug Approval News Flash: Cabozantinib (Cabometyx) Approved by FDA for Pancreatic and Extra-Pancreatic NET
【FDA Approval Alert】Exelixis's cabozantinib (Cabometyx) Approved for pNET and epNET (March 26, 2025) On March 26, 2025, the U.S. FDA approved cabozantinib (Cabometyx) for adults and pediatric patients 12 years and older with previously... -
Oncology Drug Approval News Flash: Pembrolizumab (Keytruda) Approved by FDA for HER2-Positive PD-L1 CPS ≥1 Gastric/GEJ Adenocarcinoma
【FDA Approval Alert】Merck's pembrolizumab (Keytruda) Approved for HER2-Positive PD-L1 CPS ≥1 Gastric and GEJ Adenocarcinoma (March 19, 2025) On March 19, 2025, the U.S. FDA granted regular approval to pembrolizumab (Keytruda) in combin... -
Oncology Drug Approval News Flash: Vimseltinib (Romvimza) Approved by FDA for Tenosynovial Giant Cell Tumor (TGCT)
【FDA Approval Alert】Deciphera's vimseltinib (Romvimza) Approved for TGCT (February 14, 2025) On February 14, 2025, the U.S. FDA approved vimseltinib (Romvimza) for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) wh... -
Oncology Drug Approval News Flash: Brentuximab Vedotin + Lenalidomide + Rituximab Combination Receives Accelerated FDA Approval for R/R LBCL
【FDA Approval Alert】Seagen's brentuximab vedotin combination Approved for Relapsed/Refractory Large B-Cell Lymphoma (LBCL) (February 11, 2025) On February 11, 2025, the U.S. FDA granted accelerated approval to brentuximab vedotin (Adce... -
Oncology Drug Approval News Flash: Mirdametinib (Gomekli) Approved by FDA for NF1-Associated Plexiform Neurofibromas
【FDA Approval Alert】SpringWorks's mirdametinib (Gomekli) Approved for NF1-Associated Plexiform Neurofibromas (February 11, 2025) On February 11, 2025, the U.S. FDA approved mirdametinib (Gomekli) for patients aged 2 years and older wit... -
Oncology Drug Approval News Flash: Fam-trastuzumab deruxtecan-nxki (Enhertu) Approved by FDA for HER2-Low and Ultralow Breast Cancer
【FDA Approval Alert】Daiichi Sankyo's Enhertu Approved for HER2-Low and Ultralow Breast Cancer (January 27, 2025) On January 27, 2025, the U.S. FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for adults with unresectable or metas... -
Oncology Drug Approval News Flash: Datopotamab Deruxtecan-dlnk (Datroway) Approved by FDA for HR-Positive, HER2-Negative Breast Cancer
【FDA Approval Alert】Daiichi Sankyo's Datroway Approved for HR-Positive, HER2-Negative Breast Cancer (January 17, 2025) On January 17, 2025, the U.S. FDA approved datopotamab deruxtecan-dlnk (Datroway) for adults with unresectable or me...
