Month: December 2024

FDA Authorizes Beacon’s Dreem 3S as First Sleep Wearable with Predetermined Change Control Plan, Paving the Way for Continuous Algorithm Enhancements in Sleep Monitoring

BOSTON, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Beacon Biosignals is proud to announce FDA authorization of the Predetermined Change Control Plan...

Intra-Cellular Therapies Submits Supplemental New Drug Application (sNDA) to FDA for CAPLYTA® (lumateperone) for the Treatment of Major Depressive Disorder as Adjunctive Therapy

The sNDA submission is based on positive results from Studies 501 and 502 demonstrating CAPLYTA’s robust antidepressant efficacy and favorable...

Adaptive Biotechnologies Announces Over 65 Abstracts Featuring clonoSEQ® MRD Testing Across a Range of Blood Cancers to be Presented at the 66th ASH Annual Meeting

SEATTLE, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to...

Plus Therapeutics Expands Strategic Agreement with Telix IsoTherapeutics Group for Rhenium-186 Radioisotope Supply

Five-year renewable agreement secures reliable cGMP rhenium-186 (Re-186) supply for late-stage clinical and commercial forecastsAUSTIN, Texas, Dec. 03, 2024 (GLOBE...

Cytokinetics Announces Start of COMET-HF, a Confirmatory Phase 3 Clinical Trial of Omecamtiv Mecarbil in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction

SOUTH SAN FRANCISCO, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that COMET-HF (Confirmation of...

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