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FDA Clears Covid Antigen Home Test

[ Price : $8.95]

FDA clears an ACON Laboratories 510(k) for its Flowflex Covid-19 Antigen Home Test, which was originally authorized for emergency ...

Blood Storage Container is Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies the container system for the processing and storage of red blood cell components under red...

Takedas Adzynma Approved by FDA

[ Price : $8.95]

FDA approves Takedas Adzynma, a recombinant protein product designed for prophylactic or on‑demand enzyme replacement therap...

Cyltezo Exclusivity End Dates Recommended

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The CDER Office of Therapeutic Biologics and Biosimilars recommends expiration dates for first interchangeable exclusivity for Boe...

Cogentin Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Akorns Cogentin (benztropine mesylate) Injection (1 mg/1 mL) was not withdrawn due to...

CDER Quality Office Reorganizing Next Year

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CDER announces a reorganization of the Office of Pharmaceutical Quality effective 1/14/2024.

BD Mesh Products Alert on Breast Surgery

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FDA tells healthcare providers about labeling updates to Becton Dickinsons (BD) Phasix and GalaFlex mesh products that discourage ...

FDA Approves Recor Paradise System

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FDA approves a PMA for the Recor Medical Paradise renal denervation system to treat hypertension.

CareFusion Recalls Alaris Pump Module

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Becton Dickinsons CareFusion unit recalls its Alaris Patient Controlled Analgesia infusion pump module 8120 because the compatible...

Dont Approve Amryts Filsuvez NDA: Petition

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A Lassman Law petition filed for an unidentified client asks FDA not to approve an Amryt NDA for Filsuvez to treat cutaneous manif...