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Ubrogepant, sold under the brand name Ubrelvy, is a medication used for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. [4] [5] It is not indicated for the preventive treatment of migraine. [6] Ubrogepant is a small-molecule calcitonin gene-related peptide receptor antagonist.
Once a drug receives fast track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
Drugs with accelerated approval can initially be tested in clinical trials that use a surrogate endpoint, or something that is thought to predict clinical benefit. Surrogate endpoints typically require less time, and in the case of a cancer patient, it is much faster to measure a reduction in tumor size, for example, than overall patient survival.
Guardant Health said its blood test to detect cancer that starts in the colon or rectum got an approval from the U.S. Food and Drug Administration, with the test moving closer toward gaining ...
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 ...
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 ...
An existing cancer drug has shown promise in halting Parkinson's disease progression in mouse models. More research is needed to confirm these findings. ... (FDA)-approved cancer drug already ...
The Medicaid Drug Rebate Program is a program in the United States that was created by the Omnibus Budget Reconciliation Act of 1990 (OBRA'90). The program establishes mandatory rebates that drug manufacturers must pay state Medicaid agencies related to the dispensing of outpatient prescription drugs covered by Medicaid .