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ANDA Oligonucleotide Guides Needed: AAM

[ Price : $8.95]

The Association for Accessible Medicines calls on FDA to produce several guidances for generic oligonucleotide drugs.

Subcutaneous Leqembi BLA Accepted for Review

[ Price : $8.95]

FDA accepts for review an Eisai BLA for Leqembi (lecanemab-irmb) subcutaneous autoinjector weekly maintenance dosing for treating ...

Icotec Carbon Fiber Spinal Infection Implant Cleared

[ Price : $8.95]

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

Spear Bio Gets Breakthrough Status on Alzheimer's Test

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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.