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Vertex Pharma Gets 2nd OK for Gene Therapy

[ Price : $8.95]

A month after gaining FDA approval for treating sickle cell disease with the gene therapy Casgevy, Vertex secures its second appro...

Voucher Redeemed on Fabhaltas Approval

[ Price : $8.95]

Federal Register notice: FDA announces the approval of a product that redeemed a material threat medical countermeasure priority r...

Alert on Equinoxe Shoulder Implants

[ Price : $8.95]

FDA alerts patients and healthcare providers about Exactechs Equinoxe Shoulder System joint replacement devices and possible healt...

ROi CPS Surgical Kits Recalled

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ROi CPS recalls its Regard Operative Lap P&S Surgical Kit due to sterility concerns.

Hyloris Pharma Orphan Designation for AML

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FDA grants Hyloris Pharmaceuticals an orphan drug designation for PTX-252 for treating acute myeloid leukemia.

Matsui, Buschon Introduce Drug Shortage Bill

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Reps. Matsui and Buschon introduce bipartisan legislation they say will help the federal government anticipate and mitigate drug s...

FDA Off-Label Enforcement Increasing: Attorney

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Attorney Chia-Feng Lu sees increasing FDA interest in guidance on and enforcement of off-label communications.

Court Cuts Covid Vaccine FOIA Stay to 6 Months

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The DC federal court approves a six-month stay in FDAs records production for an FOIA request from Childrens Health Defense for re...

45% of CDER Warning Letters Cited GMPs: Report

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CDER says 45% of drug Warning Letters issued in fiscal year 2023 cited GMP requirement violations.

Guide on Biologic Viral Safety Evaluations

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Federal Register notice: FDA makes available a final guidance entitled Q5A(R2) Viral Safety Evaluation of Biotechnology Products D...