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Docs Dont Understand FDA Approval Process: Research

A physician survey conducted by UCSF researchers finds many doctors dont understand how FDA approves new drugs and medical devices.

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Human Drugs

Hemogenyx Responds to Clinical Hold

Hemogenyx Pharmaceuticals files its complete response to an FDA HEMO-CAR-T clinical hold in hopes of starting Phase 1 trials.

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Human Drugs

Clinical Trial Modernization and Innovation Meeting

FDA publishes the summary of an October 2023 public meeting on continuing the Covid-19 lessons learned for modernization and innovation in clinical tr...

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Biologics

Vertex Pharma Gets 2nd OK for Gene Therapy

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

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Federal Register

Voucher Redeemed on Fabhaltas Approval

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

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Medical Devices

Alert on Equinoxe Shoulder Implants

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

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Medical Devices

ROi CPS Surgical Kits Recalled

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

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Human Drugs

Hyloris Pharma Orphan Designation for AML

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

Human Drugs

Matsui, Buschon Introduce Drug Shortage Bill

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

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Human Drugs

FDA Off-Label Enforcement Increasing: Attorney

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