Roche announces FDA approves Evrysdi tablet to treat SMA
Roche (RHHBY) announced that the Food and Drug Administration has approved a New Drug Application for an Evrysdi tablet for people living with ...
Miamisburg-based Riverain Technologies receives FDA clearance for AI-powered imaging software
A Dayton-area medical technology firm has recently had its AI-driven image processing and analysis technology cleared by the ...
Business Wire2d
LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population
LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has ac ...
The National Law Review2d
Proposed FDA Rule May Require Stricter Testing for Talc in Cosmetic Products
Recent federal developments may soon require cosmetic companies to adopt stringent precautions to ensure that talc-containing ...
Immix Biopharma receives FDA RMAT designation for NCX-201 in r/r AL Amyloidosis
Immix Biopharma (IMMX) announced that the U.S. FDA has granted RMAT designation to sterically-optimized CAR-T NXC-201 for the treatment of ...
Penn State Extension to host FSMA Produce Grower Certification course
Penn State Extension will offer a course to help produce growers meet food safety rules as outlined in the Food Safety Modernization Act, also known as FSMA, administered by the U.S. Food and Drug ...