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On Friday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc’s (NASDAQ:AZN) Datroway (datopotamab deruxtecan or Dato-DXd) for adult patients with unresectable or metastatic ...
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 ...
Several earlier drugs, including pembrolizumab, were eventually approved by the FDA for treatment of specific mutations independent of the type of cancer, but those drugs had been initially developed for specific cancer types. [14] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. [15]
(Reuters) -The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's blockbuster cancer drug, Opdivo. Opdivo is part of a class of ...
Lazertinib was approved for medical use in the United States in August 2024. [2]In November 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Lazcluze, intended in combination with amivantamab, for the treatment of non-small cell lung cancer ...
Tarlatamab, sold under the brand name Imdelltra, is an anti-cancer medication used for the treatment of extensive-stage small cell lung cancer. [4] It is a bispecific T-cell engager that binds delta-like ligand 3 and CD3.
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]
The oral drug, Brukinsa, in combination with Roche's Gazyva was approved to treat relapsed or refractory follicular lymphoma in patients who have received at least two prior lines of treatment.