Food and Drug Administration (FDA)
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The U.S. Food and Drug Administration on Friday said it plans to let medical device makers report less serious malfunctions of some devices on a quarterly basis to cut down on repeated reviews of common problems.
Shares of Agile plunged more than 62 percent in early trading after the company announced this morning the FDA rejected its low-dose hormonal contraceptive patch called Twirla.
The FDA approved Merck’s and Pfizer’s Steglatro, a SGLT2-inhibitor, that will square off against established drugs in the market.
The FDA continues to hand out some early Christmas presents to pharma companies.
The FDA broke new ground today with a first-of-its-kind therapy for eye disease.
Industry analysts were shocked when in July the FDA reversed course on Amicus’ Phase III treatment for Fabry disease.
The approval of HAnano Surface in the United States has been executed in accordance with the new 510(k) legislation for medical devices.
A look at the latest batch of FDA approvals this year.
The firm failed to submit a report to the agency of a serious injury that may have been caused by one of the company’s medical devices.
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