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Docs Dont Understand FDA Approval Process: Research

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

Hemogenyx Responds to Clinical Hold

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

Clinical Trial Modernization and Innovation Meeting

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

Vertex Pharma Gets 2nd OK for Gene Therapy

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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

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

Alert on Equinoxe Shoulder Implants

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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.