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Disappointing Data on Supernus Depression Drug

[ Price : $8.95]

Supernus Pharmaceuticals says its Phase 2b study of SPN-820 in adults with treatment-resistant depression did not demonstrate a st...

Expanded Access to TICE BCG Substitute

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FDA approves an ImmunityBIO expanded access program for recombinant BCG to help address a BCG shortage in treating bladder cancer.

What Happens to FDA in a Budget Shutdown?

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Hyman, Phelps & McNamara regulatory and medical device principal expert Richard Lewis uses his experience at FDA during the 2018-2...

AdvaMed Urges HHS Reversal of FDA Staff Cuts

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Advamed president Scott Whitaker writes HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care.

Multiple Violations at Jagsonpal Pharmaceuticals

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FDA warns Indias Jagsonpal Pharmaceuticals about CGMP deviations and other violations in its manufacturing of active pharmaceutica...

CGMP Deviations at Tyche Industries

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FDA warns Indias Tyche Industries about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Publish Guidance on Robotic Mastectomy: Petition

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Harmed Americans for Reform in Medical Device Safety asks FDA to repost two safety communications and to analyze and post its find...

Top Five 2024 FDA Data Quality Issues

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A Med Device Online guest column lists and analyzes FDAs top five data quality citation issues in 2024.

GSKs Penmenvy Vaccine for Meningococcal Disease

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FDA approves a GSK BLA for Penmenvy (meningococcal Groups A, B, C, W, and Y vaccine) for preventing invasive meningococcal disease...

Hundreds of FDA Employees Get Termination Letters

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The Trump Administration fires hundreds of FDA probationary employees over the weekend as part of its efforts to trim government f...