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Spear Bio Gets Breakthrough Status on Alzheimer's Test

[ Price : $8.95]

FDA awards Spear Bio a breakthrough device designation for its pTau 217 blood test for early diagnosis of Alzheimers disease.

Info Collection Revises ANDA Controlled Correspondence

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Federal Register notice: FDA seeks comments on an information collection revision entitled Generic Drug User Fee Program to allow ...

Califf Final Essay Touts Covid Vaccines

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As he prepares to resign his post, FDA commissioner Robert Califf posts what is likely his final essay and personal reflection on ...

Priority Review for Lung Cancer BLA

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FDA accepts for priority review an AstraZeneca and Daiichi Sankyo BLA for datopotamab deruxtecan for treating certain adult patien...

Philips Recalls ECG Mobile Monitoring App

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Philips recalls its Monitoring Service Application concerning the Mobile Cardiac Telemetry Monitoring (BTPS-1000) system after ide...

Guide on Device PMA/HDE Modular Reviews

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FDA releases guidance entitled Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) Modular Review.

Rigel Pharma Gets Orphan Status for R289

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FDA grants Rigel Pharmaceuticals an orphan drug designation for R289 and its use in treating myelodysplastic syndromes.

FDA Turmoil Before Trump: CDER Chief Quits

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CDER director Patrizia Cavazzoni unexpectedly announces her early retirement effective two days before the new Trump administratio...

18,000 Appalled Physicians Urge Senate Rejection of RFK Jr.

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Over 18,000 appalled physicians sign an open letter urging the U.S. Senate to reject the nomination of Robert F. Kennedy Jr. to se...

FDA Accepts NDA for Menkes Disease Drug

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FDA accepts for review a Fortress Biotech NDA for CUTX-101 (copper histidinate) for treating Menkes disease.