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MassDevice15h
FDA grants PMA for InspireMD CGuard Prime carotid stent, triggers $18M milestone payment
The CGuard Prime carotid stent. [Image from InspireMD] InspireMD announced that the FDA granted premarket approval (PMA) for its CGuard Prime carotid stent system. The CGuard embo ...
AstraZeneca and Daiichi Sankyo’s Datroway Approved to Treat Non-Small Cell Lung Cancer in U.S.
The drug was approved to treat patients who have already received chemotherapy under an accelerated approval process after a ...
USA Today14d
Gas station heroin: FDA warns public of tianeptine use - USA TODAY
The FDA is warning the public about a drug rising in popularity commonly referred to as as "gas station heroin." ... but it’s not approved for any medical use in the U.S.
The State14d
First Study Site Established for Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs | The State
Two parallel goals for Canalevia-CA1 (crofelemer delayed-release tablets): To obtain full approval of the drug for treatment of chemotherapy-induced diarrhea (CID) and to expand the indication of ...
The Island Packet14d
First Study Site Established for Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs
Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552. About the Jaguar Health Family of Companies. Jaguar Health, Inc. ...
westnewsmagazine17d
FDA-approved blood test for Alzheimer’s | Health | westnewsmagazine.com
On May 16, the U.S. Food and Drug Administration (FDA) announced its approval of the first blood test to aid in diagnosis of Alzheimer’s disease. The test detects amyloid plaques – a hallmark of ...
Pulmonaryhypertensionnews.com22d
Liquidia working to bring Yutrepia to US market after FDA approval
Although Yutrepia had been approved by the FDA, there was some uncertainty regarding when it could be brought to market because of a legal entanglement with United Therapeutics.United had filed a ...