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In 2001, the FDA approved use of the system for prostate surgery. The FDA has subsequently approved the system for thoracoscopic surgery, cardiac procedures performed with adjunctive incisions, and gynecologic procedures. [6] Shortly before going public, Intuitive Surgical was sued for patent infringement by Computer Motion, Inc, its chief rival.
Initially, the FDA approved implantable mesh devices due to their similarity to earlier prototypes, known as the 510(k) process. [ 16 ] [ 17 ] As patients allege long-term harm and suffering as a result of implanted mesh; the FDA released a safety communication in 2008, and led to the reclassification of surgical mesh to a class 3 or high risk ...
Zanidatamab, sold under the brand name Ziihera, is a humanized monoclonal antibody used for the treatment of HER2-positive biliary tract cancer. [1] [2] It is an IgG-like bispecific HER2-directed antibody directed against two non-overlapping domains of HER2.
Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first ...
In addition to raising nearly $19M (net) via the sale of common shares, they recently announced compelling 12-month results from their n=36 SUI feasibility study and got the green light from FDA ...
Nogapendekin alfa inbakicept was approved for medical use in the United States in April 2024. [1] [6] [7] [8] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9]
Merrimack's first FDA-approved drug was approved in 2015; Onivyde, a liposome encapsulated version of irinotecan is used for treating pancreatic adenocarcinoma. It was approved for use in the European Union the following year. [1] [2]
On Thursday, the Food and Drug Administration (FDA) approved pharmaceutical company Perrigo’s Opill, the first over-the-counter birth control pill, which will let individuals obtain the ...