FDA Approvals - Response Biomedical Files For US FDA 510(k) Market Clearance Of
Response Biomedical Files For US FDA 510(k) Market Clearance Of Rapid Influenza A+B Test (Medical News Today)
Response Biomedical Corporation (TSX-V: RBM, OTCBB: RPBIF) announced today that it has filed a US Food and Drug Administration (FDA) 510(k) submission seeking clearance to market a rapid Influenza A+B test. The test manufactured by Response will run on the RAMP(R) platform and will be marketed and sold exclusively by 3M Health Care as the 3M(TM) Rapid Detection Flu A+B Test. [click link for full ...
India's Cadila Healthcare gets FDA product approvals for three drugs (Sharewatch)
MUMBAI (Thomson Financial) - India's Cadila Healthcare Ltd said it has received product approvals from the US Food and Drug Administration for generic versions of cough reliever drug Benzonatate and analgesic drug Naproxen.
FDA Grants Ceragenix's Request for Designation (Business Wire via Yahoo! Finance)
DENVER----Ceragenix Pharmaceuticals, Inc. , a biopharmaceutical company focused on infectious disease and dermatology, today announced that the FDA's Office of Combination Products, in response to a formal request, has determined that the primary mode of action for an antimicrobial wound dressing that is currently being developed by the Company is that of a device and it has been assigned to the ...