来自MSN5 小时
FDA grants breakthrough designation for Acrivon’s endometrial cancer assay
The US Food and Drug Administration (FDA) has granted breakthrough device designation for Acrivon Therapeutics’ ACR-368 ...
JD Supra23 天
Navigating FDA’s Guidance on Validation and Verification of Analytical Testing Methods ...
The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance ...
JD Supra9 天
FDA Dumps Trio of Device-Related Guidances Prior to Administration Change
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...
Alligator Bioscience Successfully Completes End of Phase 2 Interaction with FDA For Mitazalimab
LUND, SE / ACCESS Newswire / February 6, 2025 / Alligator Bioscience (STO:ATORX) FDA feedback validates the clinical ...
BioSpace6 天
FDA Approves Vertex’s Journavx as First New Pain Drug in Decades
The greenlight for Journavx (suzetrigine), which comes on the heels of a $7.4 billion opioid settlement, could spark momentum ...
Medscape6 天
FDA OKs First-In-Class Nonopioid Pain Med Suzetrigine
Suzetrigine selectively inhibits the NaV1.8 pain-signaling pathway in the peripheral nervous system and provides effective ...
Lupus Foundation of America3 天
Allogene Therapeutics’ ALLO-329 Received FDA IND Clearance for Autoimmune Disease Trial
The U.S. Food and Drug Administration (FDA has cleared the investigational new drug (IND) application for Allogene ...