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OIG Hit FDA Accelerated Approvals

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The latest semiannual report issued by the HHS Office of Inspector General raises questions about specific FDA accelerated drug ap...

FDA Allows Companies to Skip Import Bans: Report

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A ProPublica investigative report details how a secret small group of FDA officials has approved exemptions for products from over...

Multiple Violations at Reset Technology Corp.

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FDA warns Irving, TX-based Reset Technology Corp. about Quality System and other violations in its production of two dental device...

Elevidys Shipping Nixed After 2nd Liver‑Failure Death

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Sarepta Therapeutics halts shipments of its gene therapy Elevidys (delandistrogene moxeparvovec‑rokl) to nonR...

CGMP Issues at Indias Kenil Healthcare

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FDA warns Indias Kenil Private Healthcare about CGMP violations in its production of finished drugs.

Pfizers Talzenna Gets Updated Label

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FDA approves updated labeling on Pfizers s Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with metastati...

Roche Advancing Parkinsons Drug Into Phase 3

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Roche moves prasinezumab into a Phase 3 trial after two mid‑stage trials and their open‑label extensions hinted at a d...

Milestone Pharma Files NDA Resubmission for Cardamyst

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Milestone Pharmaceuticals submits its response to a March-issued FDA complete response letter on the companys NDA for irregular he...

Zyno Medical Recalls Infusion Pumps

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Zyno Medical recalls certain Z-800 infusion pumps because they were released to customers with incorrect software versions.

Qalitex Warns of Growing FDA-Amazon Enforcement Overlap

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Qalitex Laboratories issues an alert to dietary supplement and wellness product sellers on Amazon about a growing overlap between ...