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FDA Accepts sBLA for Self-Administered FluMist

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FDA accepts for review an AstraZeneca supplemental BLA that seeks approval for a self- or caregiver-administered option for FluMis...

Comments Sought on Export Certificates

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Federal Register notice: FDA seeks comments on an information collection extension entitled Export Certificates for FDA Regulated ...

Draft Guide on Unapproved Use Promos

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Federal Register notice: FDA posts a revised draft guidance for industry entitled Communications From Firms to Health Care Provide...

Predetermined Change Control Plan Principles

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FDA and two international regulatory partners state five guiding principles for predetermined change control plans in machine lear...

Embryll Marketing Unapproved Animal Drug: FDA

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FDA says Embryll Life Sciences is illegally marketing Lanomax, an unapproved animal drug intended to treat cataracts in animals.

FDA Clears NKGen IND for Alzheimers Cell Therapy

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FDA clears an NK Gen IND trial for its Alzheimers disease cell therapy.

Zhimeng Bio Gets Orphan Status for ALS Drug

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FDA grants Shanghai-based Zhimeng Biopharma an orphan drug designation for its small-molecule KCNQ2/3 selective opener compound (C...

Medtronic PMA for Extravascular ICD Approved

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FDA approves a Medtronic PMA for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila ...

Genentechs Rozlytrek Gets Expanded Use

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FDA grants Genentech accelerated approval for an expanded use for Rozlytrek (entrectinib) in treating pediatric patients older tha...

Fresenius Recalls Some Hemodialysis Machines

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Fresenius Medical Care recalls some of its 2008 Series Hemodialysis Machines because patients may be exposed to toxic compounds th...