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FDA sends Repros Therapeutics a complete response letter on an NDA for enclomiphene for treating secondary hypogonadism in overwei...[ Price : $8.95]
Teva Pharmaceutical Industries enters into a licensing and drug-discovery agreement with Heptares Therapeutics to develop small-mo...[ Price : $8.95]
A study reported in BMJ Open says that FDA is inconsistent in its approach to the challenge of evaluating surrogate outcomes in so...[ Price : $8.95]
Federal Register Notice: FDA is making available a draft guidance for industry entitled Veterinary Feed Directive Common Format Qu...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites NVision Laser Eye Centers, One Way Drug, LLC dba Partell Specialty Pharmacy, and...[ Price : $8.95]
FDA sends Bristol-Myers Squibb a complete response letter, declining to approve a supplemental BLA for Opdivo (nivolumab) as a sin...[ Price : $8.95]
FDA clears a Siemens Healthcare 510(k) for the Multitom Rax (Robotic Advanced X-ray), a universal diagnostic imaging system intend...[ Price : $8.95]
Federal Register Notice: FDAs Psychopharmacologic Drugs Advisory Committee will meet 2/3/16 to discuss cognitive dysfunction in ma...