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Merck Breakthrough Status for Lung Cancer Drug

[ Price : $8.95]

FDA grants Merck a breakthrough therapy designation for sacituzumab tirumotecan (sac-TMT) and its use in treating certain patients...

House Covid Report Hits FDA, Others

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The House Select Subcommittee on the Coronavirus Pandemic faults many FDA actions and decisions in its 550-page report on lessons ...

Applied Therapeutics Faulted for Trial Conduct

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FDA warns New York, NY-based Applied Therapeutics about violations in its conduct of a clinical trial.

Review Voucher Issued to PTC Therapeutics

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Federal Register notice: FDA issues a priority review voucher to PTC Therapeutics for its qualified rare pediatric disease product...

Comments Extended on Smoking Cessation Products

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Federal Register notice: FDA reopens the comment period associated with a 10/21 public meeting on Advancing Smoking Cessation: Foo...

Cytokinetics NDA Filed for Hypertrophic Cardiomyopathy

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FDA accepts for review a Cytokinetics NDA for aficamten, a cardiac myosin inhibitor for treating obstructive hypertrophic cardiomy...

Baxter Recalls AK 98 Dialysis Machines

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Baxter recalls its AK 98 dialysis machines based on recent recalls by other manufacturers related to the potential risk of exposur...

Guide on Circulating Tumor DNA Biomarker Trials

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Federal Register notice: FDA makes available a final guidance entitled Use of Circulating Tumor DNA for Curative-Intent Solid Tumo...

Clinical Trial Financial Disclosure Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Financial Disclosure by Clinical Inves...

Panel Meeting to Discuss Leg Pain BLA

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Federal Register notice: FDA announces a 1/10 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss a Seika...