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FDA Oks Amgens Bkemv as Soliris Biosimilar

[ Price : $8.95]

FDA approves Amgens Bkemv as an interchangeable biosimilar for Alexions Soliris, indicated to treat two rare diseases.

J&J Reports Positive Depression Drug Data

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Johnson & Johnson reports positive topline results from its pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and saf...

Lab Association Sues FDA Over LDT Rule

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The American Clinical Laboratory Association and HealthTrackRX sue FDA to block the agencys final rule asserting authority over la...

FDA OKs Retevmo for Pediatric Thyroid Cancer

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FDA grants Eli Lilly accelerated approval for Retevmo (selpercatinib) for pediatric patients two years of age and older with advan...

Info Collection on Device De Novo Requests

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Federal Register notice: FDA seeks comments on an OMB information collection extension entitled De Novo Classification Process (Ev...

Invivyds Pemgarda Gets EUA for Covid

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Federal Register notice: FDA announces the issuance of an emergency use authorization for Invivyds Pemgarda (pemivibart) for use a...

Ostar Beauty Selling Unapproved Medical Devices: FDA

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FDA warns Chinas Ostar Beauty Sci-Tech about illegally marketing unapproved medical devices.

Multiple Violations in Lengthy Biomic Inspection

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FDA warns Charlottesville, VA-based ION Intelligence of Nature about multiple violations in its production of drugs and dietary su...

Spinearts Scarlet Anterior Cervical Cage Cleared

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FDA clears a Spineart 510(k) for its Scarlet AC-Ti secured anterior cervical cage.

Teva Spurns FDAs Beta-Lactam Drug Recommendation

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Teva says FDA should drop its recommendation for the use of dedicated manufacturing facilities for ezetimibe to prevent cross-cont...