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Review Voucher Issued to PTC Therapeutics

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Baxter Recalls AK 98 Dialysis Machines

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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...

Gottlieb Worried About RFK Jr. Pick for HHS

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Former FDA Commissioner Scott Gottlieb predicts a difficult path for Robert F. Kennedy Jr. to win Senate confirmation as HHS secre...

J&J Seeks Tremfya Approval for Pediatric Uses

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Johnson & Johnson files two supplemental BLAs for Tremfya (guselkumab) for treating certain children with moderate-to-severe plaqu...

Applied Therapeutics NDA Denied Approval

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FDA issues Applied Therapeutics a complete response letter on its NDA for govorestat and its use for treating classic galactosemia...