Drug Discovery– tag –

【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...

【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...

【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...

【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...

【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...

【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...