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Repros Gets Complete Response Letter for Enclomiphene

[ Price : $8.95]

FDA sends Repros Therapeutics a complete response letter on an NDA for enclomiphene for treating secondary hypogonadism in overwei...

Teva Adds Heptares Migraine Drug to its IND Portfolio

[ Price : $8.95]

Teva Pharmaceutical Industries enters into a licensing and drug-discovery agreement with Heptares Therapeutics to develop small-mo...

FDA Inconsistent in Drug Surrogate Evaluation: Study

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A study reported in BMJ Open says that FDA is inconsistent in its approach to the challenge of evaluating surrogate outcomes in so...

Guidance on Veterinary Feed Directive Common Format

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Federal Register Notice: FDA is making available a draft guidance for industry entitled Veterinary Feed Directive Common Format Qu...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites NVision Laser Eye Centers, One Way Drug, LLC dba Partell Specialty Pharmacy, and...

Complete Response on BMS Opdivo sBLA

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FDA sends Bristol-Myers Squibb a complete response letter, declining to approve a supplemental BLA for Opdivo (nivolumab) as a sin...

FDA Clears Siemens Robotic X-ray System

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FDA clears a Siemens Healthcare 510(k) for the Multitom Rax (Robotic Advanced X-ray), a universal diagnostic imaging system intend...

Panel to Discuss NDA/sNDA for Major Depressive Disorder

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Federal Register Notice: FDAs Psychopharmacologic Drugs Advisory Committee will meet 2/3/16 to discuss cognitive dysfunction in ma...

Comments Sought on Tobacco-Derived Products

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Federal Register Notice: FDA reopens the comment period on products made or derived from tobacco that will be subject to regulatio...

Boston Scientific Class 1 Recall of Rotawire Guidewire

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Boston Scientific begins a Class 1 recall of its RotaWire Elite Guidewire and wireClip Torquer Guidewire components because they m...