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AAPS Seeks End to Arizona Prohibition on Chloroquine

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The Association of American Physicians and Surgeons asks Arizona governor Doug Ducey to rescind a month-old moratorium forbidding ...

FDA OKs Medtronic Pediatric Dialysis Device

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FDA authorizes Medtronic to market its Carpediem continuous renal replacement therapy system for use in certain pediatric patients...

Fresenius Recall Triggers QuVa Pharma Recall

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FDA says QuVa Pharma is recalling specific lots of RECK prepared using sterile ketorolac that was recalled by Fresenius Kabi.

Remdesivir Results Show Quicker Covid-19 Recoveries

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NIHs Anthony Fauci says new clinical data show that Gileads investigational antiviral remdesivir may block Covid-19 and lead to qu...

Marks in Vaccine Consulting Role

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Politico reports that CBER director Peter Marks has been positioned by HHS as the governments leading expert on Covid-19 vaccine d...

FDA, Others Can Do More on Antibiotic Resistance: GAO

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The Government Accountability Office suggests more CDRH evaluation and monitoring of FDA-authorized tests as one of eight ways the...

Public Meeting on Modernizing Data Strategy Rescheduled

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FDA reschedules for 6/30 a public meeting to discuss possible agency-level approaches to modernizing FDAs data strategy.

Personal Genome Oncology Diagnostic Kit Cleared

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FDA clears a Personal Genome Diagnostics 510(k) for PGDx eliotissue complete, a diagnostic kit for performing genomic profiling of...

Life Spine Instruments for Spinal System Cleared

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FDA clears a Life Spine 510(k) to market implant and instrument additions to its ARx Spinal System.

Libtayo Phase 3 in Lung Cancer Stopped Early

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Sanofi and Regeneron Pharmaceuticals stop a Libtayo (cemiplimab) Phase 3 trial in lung cancer early after the primary endpoint of ...