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FDA Approves New Indications for Infuse Bone Graft

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FDA approves Medtronics Infuse Bone Graft for three additional spine surgery indications for use with certain spine implants.

FDA Colluded with Industry to Write Cures Act: Group

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Public Citizen condemns senior FDA officials for colluding with the Advanced Medical Technology Association to help write legislat...

Accelerated Approval for Genentech Cancer Drug

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FDA grants an accelerated approval for a Genentech NDA for Alecensa (alectinib) and its use in treating patients with metastatic A...

FDA Approves Wellstats Chemo Overdose Drug

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FDA approves a Wellstat Therapeutics NDA for Vistogard (uridine triacetate) for the emergency treatment of adults and children who...

FDA, OHRP Extend Comment Period on IRB Guidance

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FDA and HHS Office for Human Research Protections extend by 30 days the comment period for a joint draft guidance entitled Minutes...

Some Baclofen API May be Contaminated: FDA

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FDA cautions of potential serious risks associated with contaminated baclofen API manufactured

UK Firm Seeks Partner to Bring Ibuprofen Patch to FDA

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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

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

Review Period Set for Sirturo

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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

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