On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with advanced head and neck squamous cell carcinoma (HNSCC) that can be surgically removed and sh...
fda-approval
On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adults with recurring low-grade intermediate-risk non-muscle invasive bladder c...
fda-approval
On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a type of medicine that blocks certain enzymes, for people with advanced or spreading ROS1-posit...
fda-approval
On June 3, 2025, the Food and Drug Administration (FDA) sanctioned darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA has...
fda-approval
On May 15, 2025, the Food and Drug Administration sanctioned retifanlimab-dlwr (Zynyz, Incyte Corporation) in conjunction with carboplatin and paclitaxel for the initial treatment of people with inope...
fda-approval
On May 14, 2025, the Food and Drug Administration granted accelerated approval for telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-targeted antibody and microtubule inhibitor conjugate, for...
fda-approval
On May 14, 2025, the Food and Drug Administration sanctioned belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients aged 12 and older diagnosed with locally advanced, unresectabl...
fda-approval
On May 8, 2025, the Food and Drug Administration approved the use of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for adults with KRAS-mutated recurrent low-grade serous ovar...
fda-approval
IntroductionChimerix, a prominent biopharmaceutical firm, has declared that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Dordaviprone (ONC201). The medic...
fda-approval
On April 23, 2025, the Food and Drug Administration sanctioned penpulimab-kcqx (Akeso Biopharma Co., Ltd.) in conjunction with cisplatin or carboplatin and gemcitabine for the initial treatment of peo...
fda-approval