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Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy for hemophilia A and B.

Applied DNA Sciences, Inc. announced that its molecular diagnostics subsidiary, Applied DNA Clinical Labs, LLC, will utilize the GenXys Health Care Systems suite of clinical decision support software for interpretation and reporting of ADCL’s New York State Department of Health-approved TR8™ pharmacogenomic test.

BioSpace presents 25 noteworthy biopharma startups in ’25; analysts forecast stronger M&A as the J.P. Morgan Healthcare Conference kicks off next week; GLP-1s continue to expand their reach as Novo, Lilly fight against compounders; and a look ahead to five key FDA decisions in Q1.

Axena Health, Inc. announced that Highmark Blue Cross Blue Shield and Blue Cross Blue Shield of North Dakota have both added the Leva® Pelvic Health System as a covered benefit for their members suffering with urinary incontinence.

In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis, Miguel Forte and Ali Pashazadeh discuss the industry’s need to catch up with women’s health issues and the innovative lead the APAC region has taken in clinical trials.

Movano Health (Nasdaq: MOVE) announced that it successfully submitted updated pivotal clinical trial results as well as proof of enhanced medical device usability on April 22, 2024 to the U.S. Food and Drug Administration (FDA) as part of its 510(k) filing for the Company’s first commercial medical device, the Evie Med Ring pulse oximeter.