Phraxis Inc. today announced the successful initiation of its Post-Approval Study (PAS) for the EndoForce™ Anastomotic ...
According to Leadoptik's FDA application, the LIA catheter is an OCT-guided biopsy needle designed for use with endobronchial ...
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
In the first year of the second Trump administration, we have seen the Food and Drug Administration (FDA) take an ...
April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...
Mesoblast reports early real-world data showing 84% survival in children treated with FDA-approved Ryoncil, as the company expands hospital access and prepares an adult trial.
Intuitive Surgical receives FDA clearance for the da Vinci 5 robot to be used in cardiac procedures, reports 18% procedure ...
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
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BD gets FDA 510(k) approval for EnCor EnCompass breast biopsy system
Becton, Dickinson and CompanyBDX, popularly known as BD, recently announced that the FDA has granted 510(k) clearance for its ...
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 ...
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