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FDA Withdraws Fleming NADA

[ Price : $8.95]

Federal Register Notice/Final rule: FDA withdraws approval of a Fleming Laboratories NADA for arsanilic acid Type A medicated arti...

FDA Grants Portola Pharma Breakthrough Designation

[ Price : $8.95]

FDA grants Portola Pharmaceuticals a breakthrough therapy designation for andexanet alfa, an investigational Factor Xa inhibitor a...

CDRH Hits Genetic Test Firm with Warning Letter

[ Price : $8.95]

Concerned about a new marketing campaign, FDA tells 23andMe to immediately stop marketing its direct-to-consumer Saliva Collection...

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

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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...