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FDA Extends Mallinckrodt NDA Review for Xartemis XR

[ Price : $8.95]

FDA extends by three months its review of a Mallinckrodt NDA for its investigational compound Xartemis XR (oxycodone hydrochloride...

Avedro Ophthalmic Solution Gets Priority Status

[ Price : $8.95]

FDA grants priority review status to Avedro Inc. for an NDA for riboflavin ophthalmic solution/KXL system, a treatment of keratoco...

Repros Therapeutics Gets FDA Meeting for Androxal

[ Price : $8.95]

Repros Therapeutics says FDA has granted a face-to-face meeting to discuss pivotal efficacy studies for Androxal, an orally active...

Cubist Antibiotic for UTIs Meets Primary Endpoint

[ Price : $8.95]

Cubist Pharmaceuticals reports positive results from its Phase 3 clinical trial of antibiotic ceftolozane/tazobactam in patients w...

Ventrus Plans NDA for Anal Fissure Treatment

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Ventrus Biosciences completes enrollment of a second Phase 3 trial of its diltiazem hydrochloride 2% cream in patients with pain r...

Preclinical Assessment of Cellular/Gene Therapy Products

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Federal Register Notice: FDA releases a guidance: Preclinical Assessment of Investigational Cellular and Gene Therapy Products.

Guidance on Research IVD Product Distribution

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Federal Register Notice: FDA releases a guidance: Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or In...

FDA Lifts Avandia Restrictions Based on New Data

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FDA lifts prescribing and dispensing restrictions on rosiglitazone-containing diabetes drugs based on new data that do not show an...

A New FDA Wrinkle? Just Dont Approve Nasty Products

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Washington commentator Bob Steeves says FDA may be deliberately refusing to approve any new tobacco products, thereby choking off ...

FDA Raises Many Ampligen Concerns

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FDA tells the Arthritis Advisory Committee it has concerns about the efficacy and safety of Hemispherx Biopharmas Ampligen in trea...