Reached alignment with FDA on key elements of registrational development plan for LX2006, including accelerated approval pathway with left-ventricular mass index (LVMI) and frataxin protein expression ...
That approval pathway is for devices that are similar to products that are already approved for market. GE HealthCare said the system would offer new capabilities in clinical imaging and neuroscience ...
Clene’s cash, cash equivalents and marketable securities totaled $14.6 million as of September 30, 2024, compared to $35.0 million as of December 31, 2023. Clene expects that its resources as of ...
Autolus Therapeutics ( (AUTL) ) has provided an announcement. Autolus Therapeutics has achieved a pivotal milestone with the FDA’s ...
With FDA approval of an investigational device exemption, J&J’s soft tissue robot moves a step closer to challenging ...
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
Axsome Therapeutics' Q3 2024 earnings report shows a revenue beat with $104.8m. See why I think selling AXSM stock on any ...
our ability to work with our third-party contract manufacturing organization ("CMO") and the FDA to adequately address the issues raised in the CRL and execute on a pathway forward for the potential ...
“We also announced that the FDA has approved our IDE application allowing us to move ... InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR. We routinely post information ...
REDWOOD CITY, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or the Company, Nasdaq: CHRS), today reported financial results for the quarter ended September 30, 2024 and ...
In the rainy season of 2020, the Forestry Development Authority (FDA) investigated the scale of abandoned logs in Grand Bassa ...
The FDA has approved a new oral antibiotic to treat uncomplicated urinary tract infections. Orylnvah is a broad-spectrum oral penem antibiotic for women who have limited or no alternative ...
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