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FDA Advises Phase 3 Trial for ERC-USAs ERC Glioblastoma Vaccine

[ Price : $8.95]

FDA recommends that ERC-USA and the University of California, Irvine, pursue a confirmatory Phase 3 registration trial for ERC 167...

FDA OKs Bauschs ClearVisc Viscosurgical Device

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FDA approves Bausch + Lombs ClearVisc dispersive ophthalmic viscosurgical device (OVD) for use in ophthalmic surgery.

FDA Approves New Erbitux Dosing Regimen

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FDA approves a new dosage regimen 120-minute intravenous infusion every two weeks for Imclones Erbitux (cetuximab) for treating ...

Qmart Recalls Products with Undeclared Ingredients

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Qmart recalls all lots of its Imperial Gold 2000, PremierZen Extreme 3000, Burro en Primavera 60000 and Imperial Platinum 2000 aft...

FDA Advisors to Review FibroGen Roxadustat NDA

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In preparation for a 7/15 FDA advisory committee meeting to consider a FibroGen NDA for roxadustat, the company clarifies some of ...

Curex Marketing Unapproved Allergy Drops: FDA

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CBER cautions Curex, Inc., New York, NY, that it is unlawfully marketing and distributing allergy drops and drop compounds.

RPK Drug Cream Label Doesnt Match Listed Drug Name: FDA

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FDA warns RPK Pharmaceuticals about a listing discrepancy for a drug cream it manufactures.

Part of Whistleblower Medtronic Spinal Device Suit Can Proceed: 9th Circuit

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The 9th Circuit Court of Appeals reverses part of a California federal court decision that dismissed all whistleblower claims agai...

No Movement on Nominating FDA Commissioner

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The Biden Administration shows no signs of moving to nominate an FDA commissioner, which could leave current acting commissioner J...

7 Observations in Wells Pharmacy Inspection

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FDA releases the FDA-483 issued following an inspection at the Wells Pharmacy, Dyersburg, TN, outsourcing facility.