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The approval allows the use of the cancer drug, Rybrevant, in combination with J&J's existing drug, lazertinib, as a first-line treatment for non-small cell lung cancer (NSCLC) patients with a ...
On Wednesday, the FDA approved Merus N.V.’s (NASDAQ:MRUS) Bizengri (zenocutuzumab-zbco) as the first and only treatment indicated for adults with pancreatic adenocarcinoma or non–small cell ...
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 ...
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.
granted for three indications: HER2-positive breast cancer with prior anti-HER2-based treatment; HER2 low (IHC 1+ or IHC 2+/ISH) breast cancer; and non-small cell lung cancer with an activating HER2 mutation Dupilumab: Regeneron Pharmaceuticals: granted for two indications: eosinophilic esophagitis; and atopic dermatitis: Ivosidenib: Servier ...
In October 2020, the U.S. FDA approved the combination of nivolumab with ipilimumab for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. [32] This is the first drug regimen approved for mesothelioma in sixteen years and the second FDA-approved systemic therapy for mesothelioma. [32]
Full approval was granted by the FDA in August 2018. [8] The FDA approval was based on a clinical trial of 372 participants with relapsed mycosis fungoides or Sézary syndrome who received either mogamulizumab or a type of chemotherapy called vorinostat. The FDA granted the application for mogamulizumab priority review, breakthrough therapy ...
The FDA bestows a Breakthrough Therapy designation to Syndax's (SNDX) revumenib for treating patients with relapsed/refractory acute leukemia harboring a KMT2A rearrangement. Stock up.