ACR-368 OncoSignature assay gains FDA breakthrough status
Acrivon Therapeutics, Inc. (NASDAQ: ACRV), a clinical stage biopharmaceutical company with a market capitalization of $184 million and an impressive 60% stock return over the past year, announced that ...
Acrivon Therapeutics Gets FDA Breakthrough Device Designation for Cancer Identification
Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of ...
Rezolute, Inc.: Rezolute Provides Update on its Phase 3 sunRIZE Study of Ersodetug for the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism
Open-label arm (infant participants DMC approved enrollment of infants into the double-blind portion of the study sunRIZE enrollment completion expected in Q2 2025, subject to outcomes from upcoming ...
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FDA Approves Non-Opioid Treatment for Moderate to Severe Acute Pain as Agency Continues to Take Steps to Support New Approaches for Pain Management
FDA Approves Non-Opioid Treatment for Moderate to Severe Acute Pain as Agency Continues to Take Steps to Support New ...
Medindia5d
FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
First Drug Approved in New Class of Non-Opioid Pain Medicines; Agency Continues to Take Steps to Support New Approaches for Pain Management Journavx is the first drug to be approved in this new class ...
FDA approves Vertex's first-in-class non-opioid analgesic for acute pain
Today, the U.S. Food and Drug Administration (FDA) gave its approval to Vertex Pharmaceuticals' (NASDAQ: NASDAQ:VRTX) Journavx (suzetrigine) 50 milligram oral tablets. This new drug is a non-opioid ...
JD Supra5d
CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...
Vincerx Pharma and Oqory reveal merger and cancer drug data
SAN MATEO, Calif. - Vincerx Pharma, Inc. (NASDAQ:VINC), a clinical-stage biopharmaceutical company with a current market capitalization of $2.77 million, and Oqory, Inc. announced promising results ...
AstraZeneca's Enhertu gets additional FDA approval
AstraZeneca (AZN) and Daiichi Sankyo's (DSKYF) drug Enhertu has been approved by the FDA for the treatment of certain breast cancer patients. Read more here.
Spectral AI, Inc.: Spectral AI Provides Update to Investors
Spectral AI (NASDAQ: MDAI) ("Spectral AI" or the "Company"), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from ...
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Spectral AI Provides Update to Investors
DALLAS, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView ® System, which received Breakthrough Device Designation from ...