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In February 2022, AbbVie requested approval by the US Food and Drug Administration (FDA) for adjunctive treatment for major depressive disorder. [43] Approval was granted by the FDA in December 2022 for cariprazine to be used as an adjunctive treatment for major depressive disorder. [44]
Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. [3]
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 ...
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 ...
Gepirone is indicated for the treatment of major depressive disorder (MDD) in adults. [1] Of 15 clinical trials of gepirone for major depressive disorder submitted to the U.S. Food and Drug Administration (FDA), three were excluded for methodological reasons, three were deemed "failed" and "uninformative", seven were deemed negative and did not demonstrate effectiveness, and two were deemed ...
(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 ...
In 2003 Public Citizen filed a citizen petition asking the FDA to withdraw the marketing authorization in the United States, and in early 2004 the organization sued the FDA to attempt to force withdrawal of the drug. [43] [44] The FDA issued a response to the petition in June 2004 and filed a motion to dismiss, and Public Citizen withdrew the ...
Asenapine has been approved by the FDA for the acute treatment of adults with schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. [12] In Australia asenapine's approved (and also listed on the PBS) indications include the following: [14] Schizophrenia