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In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
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 ...
The FDA assigns a Breakthrough Therapy status to AstraZeneca's (AZN) Enhertu for treating patients with metastatic NSCLC whose tumors have a HER2 mutation.
Fidanacogene elaparvovec was approved for medical use in Canada in December 2023, [1] in the United States in April 2024, [9] and in the European Union in July 2024. [6] The FDA granted the application breakthrough therapy designation.
The company announced in July 2024 that the FDA had accepted a new drug application for suzetrigine. [11] The FDA granted the application for suzetrigine priority review, fast track, and breakthrough therapy designations. [2] [11] In January 2025, the FDA granted approval of Journavx to Vertex Pharmaceuticals. [2]
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.
The US Food and Drug Administration (FDA) granted the application for belantamab mafodotin priority review, orphan drug, and breakthrough therapy designations. [ 5 ] In 2023, the confirmatory phase III DREAMM-3 trial aimed to compare belantamab mafodotin versus pomalidomide plus low-dose dexamethasone in participants with relapsed or refractory ...
The FDA grants Breakthrough Therapy designation to Bristol-Myers Squibb's (BMY) Orencia for the prevention of moderate-to-severe acute GvHD in hematopoietic SCT from unrelated donors.