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Allogene Myeloma Therapy Gains Regenerative Medicine Status

[ Price : $8.95]

FDA grants Allogene Therapeutics a Regenerative Medicine Advanced Therapy designation for ALLO-715 and its use in relapsed/refract...

Opioid Vaccine Being Developed

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Researchers say they are developing an adjuvant opioid use disorder vaccine.

FDA Generic Drug Activities Reports

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FDA releases statistics for the first two quarters of FY 2021 on actions relating to section 505(j) ANDAs.

Emergent Bio Covid Vaccine 9-Item FDA Form-483

[ Price : $8.95]

FDA releases a nine-item Form-483 less than 24 hours after it completed an inspection of Emergent BioSolutions Baltimore manufactu...

FDA Approves Medtronic Pipeline Device

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FDA has approved the Medtronic Pipeline Flex embolization device with the companys proprietary Shield Technology.

FDA Denies Cell2in Cell-Based Therapy Petition

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FDA denies a Cell2in petition seeking inclusion of GSH monitoring in certain guidances as a means to measure the potency of cellul...

LivaNova Blood-Gas Monitor for Heart-lung Machine

[ Price : $8.95]

FDA clears a LivaNova 510(k) for B-Capta, an in-line, blood-gas monitoring system integrated into its S5 heart-lung machine.

J&J Cataract Surgical Device Cleared

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FDA clears a Johnson & Johnson Vision 510(k) for its Veritas Vision System, a phacoemulsification (cataract surgery) device that a...

FDA Should Disclose Confidential Drug, Vaccine Data: Article

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Two Yale Law School professors suggest changes to FDA to create a clinical trial publicity regime exposing confidential data.

FDA HCT/P Enforcement Discretion Ending 5/31: Marks

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CBER director Peter Marks says enforcement discretion for IND and premarket application requirements for certain regenerative medi...