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The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung ...
(Reuters) -The U.S. Food and Drug Administration on Tuesday approved Johnson & Johnson's chemotherapy-free combination treatment for a type of non-small cell lung cancer, setting up a challenge ...
Gallium (68Ga) gozetotide was approved for medical use in the United States in December 2021, [13] [14] and in the European Union in December 2022. [10] It is the first drug approved by the US Food and Drug Administration (FDA) as a PET imaging agent.
Lutetium (177 Lu) vipivotide tetraxetan was approved for medical use in the United States in March 2022, [6] [10] and in the European Union in December 2022. [7] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication .
The therapy, branded as Tevimbra, was approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma. The American Cancer Society estimates there ...
Dostarlimab was approved for the treatment of endometrial cancer in both the United States and the European Union in April 2021. [5] [6] [11] [8] [12] Based on the Garnet trial, dostarlimab gained accelerated approval from the US Food and Drug Administration (FDA) in April 2021, [6] and full approval in February 2023. [7]
[3] [6] [7] This was the first time a radiopharmaceutical had been approved for the treatment of GEP-NETs in the United States. [6] The US Food and Drug Administration (FDA) approved 177 Lu dotatate based primarily on evidence from one clinical trial, NETTER-1 of 229 participants with somatostatin-receptor positive midgut GEP-NETs. [15]
Regeneron said "it was the first time" a CRL for this reason was issued by the U.S. Food and Drug Administration, which has been lately working to raise the bar for cancer drug developers seeking ...