The US Food and Drug Administration (FDA) on Monday finalized guidance to pharmaceutical and biotech sponsors looking for more advice on when non-inferiority studies demonstrating effectiveness of an ...
Signati™ Medical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) application for a randomized pivotal clinical ...
All new antibiotics approved by the US Food and Drug Administration (FDA) used surrogate outcome measures, and about half had pivotal trials with a non-inferiority design, according to recent research ...
Prosigna identified a large high-clinical-risk subgroup with minimal chemotherapy benefit, estimated to avert at most two recurrences per 100 patients treated. Enrollment broadened prior assay use by ...
Paris, France, 14-17 May 2024. The Course Directors have selected 3 major Late Breaking Trials (LBTs) that will be presented for the first time during the 2024 edition of EuroPCR. These trials were ...
New study findings show that utilizing super-high-pressure non-compliant balloons (NCB) is non-inferior to intravascular lithotripsy (IVL) balloon catheters for lesion preparation and stent expansion ...
Please provide your email address to receive an email when new articles are posted on . Tapering regimens were linked to significantly higher flare risk among patients in RA remission. The results ...
Novartis NVS reported positive top-line data from a late-stage study of its investigational new malaria treatment candidate, KLU156 (ganaplacide/lumefantrine, or ...
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