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Actuate Gets Orphan Status for Pancreatic Cancer

[ Price : $8.95]

FDA grants Actuate Therapeutics an orphan drug designation for elraglusib for treating patients with pancreatic cancer.

FDA Warns Intas About Multiple Violations

[ Price : $8.95]

FDA warns Indias Intas Pharmaceuticals about CGMP and other violations at its drug manufacturing facility in Sanand, India.

Iso-Tex Diagnostics CGMP Issues

[ Price : $8.95]

FDA warns Alvin, TX-based Iso-Tex Diagnostics about CGMP violations in its production of finished drugs.

CGMP Violations at Baxter India Facility

[ Price : $8.95]

FDA warns Baxters Ahmedabad, India-based drug manufacturing facility about CGMP and other violations.

Teleflex QuikClot Device Expanded Use Cleared

[ Price : $8.95]

FDA clears a Teleflex 510(k) for expanded use for the QuikClot Control+ Hemostatic Device mild and moderate bleeding in cardiac s...

GSK Wins Expanded Use for Jemperli

[ Price : $8.95]

FDA approves a GSK supplemental BLA for Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by single-...

Numares LDL Test for Cardiovascular Disease

[ Price : $8.95]

FDA clears a Numares Health 510(k) for the Axinon LDL-p Test System, a test physicians can use to measure lipoproteins for patient...

FY 2024 Device User Fee Rates Set

[ Price : $8.95]

FDA announces the FY 2024 user fee rates for medical device submissions.

Drug/Biologic User Fee Rates for FY 2024

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Federal Register notice: FDA announces the rates for prescription drug/biologic user fees for fiscal year 2024.

Senate Bill Introduced on Drug Shortages

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Three Democratic U.S. Senators introduce the Drug Shortages Prevention and Quality Improvement Act that would give FDA and CMS add...