This week, the Trump administration announced that the FDA had approved leucovorin, a generic drug, as a treatment for autism ...
The agency expanded use of an old drug as a treatment for some people with autism. The endorsement sent some customers ...
Shaji Kumar, MD, Mayo Clinic, touches on the complexities of the drug approval process and examines how manufacturing challenges can delay FDA approval. He also returns to the guidelines update and ...
This seminar offers key market opportunities by enhancing understanding of FDA device regulatory processes, including 510(k), IDE, PMA, HDE, and De Novo applications. It emphasizes pre-submission ...
Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...
Cancer immunotherapies, anti-cancer treatments that target a patient’s own immune system, working to make it more effective, have revolutionized the | Cancer ...
Medtronic (NYSE: MDT) today reported the first patient treated with its Altaviva neuromodulation device for urge urinary ...
The FDA’s proposed Rare Disease Evidence Principles review process is a starting point for getting rare disease therapies ...
AngioSafe® announced its emergence from stealth with 510(k) clearance from the U.S. FDA for the Santreva™-ATK Endovascular Revascularization Catheter.
Dr. Erik Langhoff, chief medical officer and consultant for the Bronx Regional Health Information Organization, discusses how ...
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