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Medical Devices

Icotec Carbon Fiber Spinal Infection Implant Cleared

FDA clears an Icotec 510(K) for the use of its BlackArmor carbon/PEEK implants for treating de novo spinal infections.

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Medical Devices

Spear Bio Gets Breakthrough Status on Alzheimer's Test

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

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FDA General

Info Collection Revises ANDA Controlled Correspondence

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

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Biologics

Califf Final Essay Touts Covid Vaccines

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

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Human Drugs

Priority Review for Lung Cancer BLA

FDA accepts for priority review an AstraZeneca and Daiichi Sankyo BLA for datopotamab deruxtecan for treating certain adult patients with locally adva...

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Medical Devices

Philips Recalls ECG Mobile Monitoring App

Philips recalls its Monitoring Service Application concerning the Mobile Cardiac Telemetry Monitoring (BTPS-1000) system after identifying that some e...

Medical Devices

Guide on Device PMA/HDE Modular Reviews

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

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Human Drugs

Rigel Pharma Gets Orphan Status for R289

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

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Human Drugs

FDA Turmoil Before Trump: CDER Chief Quits

CDER director Patrizia Cavazzoni unexpectedly announces her early retirement effective two days before the new Trump administration comes to power.

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FDA General

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

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