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Arrowhead Acquires Priority Voucher to Speed Plozasiran Expanded Indication

[ Price : $8.95]

Arrowhead Pharmaceuticals agrees to acquire an FDA Rare Pediatric Disease Priority Review Voucher from an undisclosed third party ...

Suggestions for FDA Draft Guidance on Some Oncology Studies

[ Price : $8.95]

Four stakeholders praise an FDA draft guidance on streamlining some oncology nonclinical safety studies and recommend improvements...

Dabur India CGMP Violations

[ Price : $8.95]

FDA warns Dabur India Limited about CGMP violations in its production of finished drugs.

Quality System Issues at Koven Technologies

[ Price : $8.95]

FDA warns St. Louis, MO-based Koven Technologies about QSMR issues in its manufacturing and marketing of the Bidop 3 Doppler.

FDA Aims to Modernize Inspection Program

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FDA undertakes a broad modernization of its inspection program, including expanded use of risk-based oversight, greater reliance o...

FDA Finalizes Updated Device Human Factors Guidance

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FDA issues an updated final guidance entitled Applying Human Factors and Usability Engineering to Medical Devices.

Lilly Gets Breakthrough Status for Pancreatic Cancer Therapy

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FDA grants Eli Lilly a breakthrough therapy designation for olomorasib as a monotherapy for treating adult patients with advanced ...

Sandoz to Pay $479 Million in Generic Drug Price-Fixing Litigation

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Sandoz reaches agreements totaling about $479 million to resolve most of its remaining exposure in long-running U.S. litigation al...

FDA Experts Back 'Operation Trialblazer' But Warn Agency Still Needs Stability

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FDA regulatory experts support the agency's new "Operation Trialblazer" initiative as an important step toward accelerating drug d...

FDA Cites Australian Drug Manufacturer for Quality System, Testing Deficiencies

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FDA cites Australian manufacturer Veganic SKN Limited for multiple current good manufacturing practice deficiencies following a 7/...