The FDA has approved a before and after surgery regimen for pembrolizumab to improve outcomes in resectable locally-advanced head and neck squamous cell carcinoma (HNSCC). Specifically, […]
The FDA has approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The intravesical mitomycin formulation is meant to be […]
The FDA has approved taletrectinib (Ibtrozi, Nuvation Bio) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in first- and later-line settings, regardless of […]
The Medicines and Healthcare products Regulatory Agency (MHRA) has reiterated that women using weight-loss drugs must use effective contraception, as the risks of these drugs to […]
The US Food and Drug Administration (FDA) has approved single-agent darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals, Inc.) for the treatment of metastatic castration–sensitive prostate cancer (mCSPC). Darolutamide, […]
Pfizer was taken to task at a recent meeting of the US Food and Drug Administration (FDA)’s Oncologic Drugs Advisory Committee (ODAC) for attempting to expand […]
The National Institute for Health and Care Excellence (NICE) has recommended sparsentan (Filspari, Vifor Pharma) for treating primary immunoglobulin A nephropathy in adults. The recommendation reverses […]
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended several changes to the way the antibiotic azithromycin is used in the EU, including […]
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion for Blenrep (belantamab mafodotin) for the […]
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