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Using ctDNA as an Early Endpoint

[ Price : $8.95]

Panelists at a Friends of Cancer Research meeting discuss the next steps to help make circulating tumor DNA available as an early ...

Bone Bolt System Cleared by FDA

[ Price : $8.95]

FDA clears a University of Utah Orthopedic Innovation Center 510(k) for its Bone Bolt System, an implant for percutaneous bone fra...

FDA Monitoring Drug Shortages After Pfizer Tornado

[ Price : $8.95]

FDA says it is working with Pfizer to monitor the potential for drug shortages after a 7/19 tornado severely damaged Pfizers large...

Info Collection on Blood Product GMPs

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Current Good Manufacturing Practice for Bloo...

FDA Announces 7 Info Collections Approved

[ Price : $8.95]

Federal Register notice: FDA announces that seven information collections have been approved by OMB.

Astria Gets Fast Track for Angioedema Drug

[ Price : $8.95]

FDA grants Astria Therapeutics fast track status for STAR-0215 for treating hereditary angioedema.

FDA OKs Vanflyta for Leukemia

[ Price : $8.95]

FDA approves a Daiichi Sankyo NDA for Vanflyta (quizartinib) in certain patients with newly diagnosed acute myeloid leukemia.

New FDA Tools in Democrats Preparedness Bill

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All Democrats on the House Energy and Commerce Committee sponsor legislation to reauthorize the Pandemic and All-Hazards Preparedn...

Dont Use Quidel Triage Cardiac Panel: FDA

[ Price : $8.95]

FDA says healthcare providers, laboratories, and facilities should immediately stop using the Quidel Triage Cardiac Panel due to i...

Ex-FDA Gene Therapy Guru Joins Greenleaf

[ Price : $8.95]

Former CBER Office of Tissues and Advanced Therapies director Wilson Bryan joins regulatory consulting firm Greenleaf Health as e...