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FDA Accepts NDA for New Thiola Formulation

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FDA accepts for review a Retrophin NDA for a new formulation of its Thiola (tiopronin) tablets for treating cystinuria.

Priority Review for Lynparza sNDA in Ovarian Cancer

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FDA accepts for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) as a maintenance treatment in ce...

Sen. Grassley Seeks FDA Response on Cybersecurity Report

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Sen. Judiciary Committee chairman Chuck Grassley (R-IA) steps up pressure on FDA after a recent HHS Inspector General (OIG) report...

Palvella Therapeutics Gains Fast Track for PTX-022

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FDA grants Palvella Therapeutics a fast track designation for its lead product candidate PTX-022 (rapamycin topical formulation) f...

Pain Therapeutics Appeals Denial of Pain Drug

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Pain Therapeutics appeals an August-issued FDA complete response letter for Remoxy, an abuse-deterrent, extended-release form of o...

Latest Federal Register Notices

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FDA Review post the Federal Register notices for the week ending 11/9/2018.

Yupelri Approved for COPD Maintenance

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FDA approves a Theravance Biopharma and Mylan NDA for Yupelri (revefenacin) inhalation solution for the maintenance treatment of p...

FDA OKs Emergency Use Ebola Fingerstick Test

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FDA issues Chembio Diagnostic Systems an emergency use authorization for its DPP Ebola Antigen System, a rapid, single-use test fo...

Senators Ask Trump to Support Pay-for-delay Bill

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U.S. Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) send a letter to the President urging him to support legislation to limi...

FDA Modernizing Inspections with New Protocols

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After several years of planning, FDA says it implementing its New Inspection Protocol Project to modernize inspections with a new ...