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The Charité, a mobile core device for use in the lumbar spine, was approved first, in 2004, but is no longer in use. prodisc, the longest continually used disc replacement device in the US, is a fixed core device manufactured by Centinel Spine and was approved in 2006 for the lumbar spine with a cervical device approved in 2007.
It was the second device to be approved by the FDA for such a purpose. As a condition of approval, Synthes Spine is required to conduct a five-year study assessing the long-term safety and effectiveness of the disc. The study will include the 286 patients who participated in the pre-approval clinical trials.
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 Food and Drug Administration (FDA) recently approved the nasal spray Spravato for the treatment of major depression in people who have not responded to at least two oral antidepressants.
A woman went viral for meeting a romantic partner in a Home Depot. Katelyn Ansari tells us about her relationship and why it's good to meet people in person.
The U.S. FDA's assent for the therapy, to be sold under the brand Ohtuvayre, is the company's first and provides a new inhaled non-steroidal treatment for chronic obstructive pulmonary disease.
In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA's approval process. Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical ...
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 ...
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