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No FDA Funding for RADAR: Public Citizen

[ Price : $8.95]

Public Citizen asks FDA to revise its planned research on the misuse of drugs and other substances to ensure that no funding goes ...

FDA Alert on Synovo Hip Implants

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FDA alerts healthcare providers to not purchase or implant Synovos Total Hip System because modifications to the original device d...

EUA Filed for Covid Prevention in Immunocompromised

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Invivyd seeks FDA emergency use authorization for VYD222, which is described as a broadly neutralizing, half-life extended monoclo...

FDA OKs Arcutis Zoryve Topical Foam for Dermatitis

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FDA approves Arcutis Biotherapeutics Zoryve topical foam to treat seborrheic dermatitis in individuals aged nine and older.

Complete Response Letter for Zealand Infant Drug

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FDA issues a complete response letter for Zealand Pharmas dasiglucagon based on deficiencies at a third-party manufacturing facili...

FDA Updates Kite Yescarta Label

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FDA approves a label update for Kites Yescarta to include the overall survival primary analysis from the landmark Phase 3 Zuma-7 s...

No Info from Singapore Drug Company

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FDA warns Singapores Wipro Unza Singapore Private, Limited, about refusing to respond to two agency records requests for informati...

FDA Approves Ionis/AstraZenecas Wainua

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FDA approves Ionis/AstraZenecas Wainua to treat adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis.

Quality System Issues at Argentinas Terragene

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FDA warns Argentinas Terragene S.A. about Quality System violations in its manufacturing of Biological and Chemical Sterilization ...

Turkish Drug Company Has CGMP Issues: FDA

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FDA warns Avcilar/Istanbul, Turkey-based Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi about CGMP violations...