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Human Drugs

FDA Warns 6 Firms on Unapproved Fat-Dissolving Drugs

FDA warns six companies that they are marketing unapproved fat-dissolving drugs.

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Human Drugs

Sydnexis NDA Accepted for Pediatric Myopia

FDA accepts a Sydnexis NDA for SYD-101 (topical low-dose atropine) for treating progression of pediatric myopia.dr

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Human Drugs

Top Device Science Official Leaves FDA

CDRH chief scientist and deputy Center director Doug Kelly abruptly resigns after less than five years at the agency.

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FDA General

FDA Taps Jim Traficant as Chief of Staff

FDA names former business consultant Jim Traficant as chief of staff where he will oversee and lead the agencys major initiatives.

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Human Drugs

Mineralys Nets Positive Data in Hypertension Drug Studies

Mineralys Therapeutics reports positive topline data from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials assessing lorundrostat...

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Human Drugs

FDA Clarifies Compounding Policy for GLP-1 Products

FDA clarifies its policies for compounders of GLP-1 products for weight-loss and treating diabetes following a court ruling in Texas that denied a pre...

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Medical Devices

Dexcom Hit With Warning After 2 Inspection

Dexcom says it received an FDA Warning Letter following inspections at the companys facilities in San Diego, CA and Mesa, AZ.

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FDA General

FDA Staff Given $25,000 Buyout Offers

HHS offers its 80,000 federal employees, including FDA, up to a $25,000 buyout to retire or leave their government employment as part of new move to c...

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Human Drugs

Glenmark Pharma Hit With 483 After India Inspection

FDA belatedly inspects Indias Glenmark Pharmaceuticals after a recent ProPublica investigative report found that the agency hadnt shifted any attentio...

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Human Drugs

Fresenius Kabi Recalls Ivenix Infusion Software

Fresenius Kabi recalls its Ivenix LVP software that is embedded in its Ivenix Infusion System due to reports about certain anomalies associated with t...