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Mavacamten was approved for medical use in the United States in April 2022. [ 8 ] [ 12 ] [ 13 ] [ 14 ] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication . [ 15 ] [ 16 ]
Mosunetuzumab was approved for medical use in the European Union in June 2022, [4] and in the United States in December 2022. [ 3 ] [ 7 ] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication .
A new opioid-free pain medication was approved by the U.S. Food and Drug Administration (FDA) on Thursday, marking a non-addictive alternative for patients. Journavx (suzetrigine), made by Vertex ...
The gene therapy will compete with Australia-based CSL Behring’s Hemgenix, a similar treatment that won FDA approval for hemophilia B in 2022. That drug has a similar list price of $3.5 million ...
Janssen filed for approval from the FDA in December 2022, [18] and from the European Medicines Agency in January 2023. [ 19 ] On 20 July 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the ...
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 ...
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 ...
In April 2023, upadacitinib was approved in the EU for the treatment of moderately to severely active Crohn's disease in adults. [21] [22] [23] In May 2023, the FDA approved upadacitinib for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers.