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FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

Stereotaxis, Inc. (STXS) Q3 2025 Earnings Call Transcript

Q3 2025 Earnings Call November 11, 2025 4:30 PM ESTCompany ParticipantsDavid Fischel - CEO & ChairmanKimberly Peery - ...

BBOT Reports Third Quarter 2025 Financial Results and Update on Corporate Progress

BBOT debuted as a publicly traded company focused on optimized target coverage for patients with tumors driven by RAS and ...

U.S. FDA Approves KYGEVVITM (Doxecitine And Doxribtimine), The First And Only Treatment For Adults And Children Living With Thymidine Kinase 2 Deficiency (Tk2d)

The First And Only Treatment For Adults And Children Living With Thymidine Kinase 2 Deficiency (Tk2d). <li /> Approved indication: KYGEVVITM (doxecitine and doxribtimine) powder for oral solution (2 ...

Cytosorbents Corp: CytoSorbents Reports Third Quarter 2025 Financial Results and Provides Business Update

Third quarter 2025 revenue of $9.5 million, up 10% year-over-year Amended credit agreement with Avenue Capital Group which strengthens our balance sheet with ...

BioCardia, Inc.: BioCardia Reports Third Quarter 2025 Business Highlights and Financial Results

BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, ...