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UK Firm Seeks Partner to Bring Ibuprofen Patch to FDA

[ Price : $8.95]

UK-based Medherant seeks a co-development partner to get FDA approval for worlds first-ever transdermal ibuprofen patch and others...

FDA Sets Review Period for Fulyzaq

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for Napo Pharmaceuticals Fulyzaq for the purpose of patent ex...

Review Period Set for Sirturo

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for Janssens Sirturo for the purpose of patent extension.

Review Period Set for Visual Stimulation System

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory for Second Sight Medical Products Argus II Visual Stimulation System for th...

Review Period Set for Bayer Animal Healths Veraflox

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for Bayer Animal Healths Veraflox for the purpose of patent e...

Justice Official: Money Penalties Not Enough in Settlements

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Justice Department official says the days of a money-only penalty in corporate criminal settlements is long over and company offic...

9,469 Malfunctions in Tests Califf Oversaw: Public Citizen

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Public Citizen says its analysis of FDA records shows many reports of INRatio injuries and malfunctions in patients before a clini...

FDA Priority Review for Pfizer Ibrance sNDA

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FDA accepts for priority review a Pfizer supplemental NDA for its breast cancer medication, Ibrance (palbociclib) for an expanded ...

Conflicting Morcellator Research

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An online study sets the rate of leiomyosarcoma among women undergoing morcellation at 1 of 429 per 1,000 hysterectomies, riskier ...

Comments Sought on Enhanced Transparency Submissions

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Federal Register Notice: FDA seeks comments on a proposed collection of information on interviews of pharmaceutical manufacturers ...