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Can-Fite to Begin Phase 2 Study in Advanced Liver Cancer

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Can-Fite BioPharma plans a Phase 2 study under an open IND with FDA of its drug CF102 in 130 patients with advanced liver cancer.

FDA Approves Advanced Bionics Ear Sound Processor

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FDA approves an Advanced Bionics PMA for its new Naida CI Q70 sound processor for cochlear implants.

CDER Names Guettier as Endocrinology Acting Director

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CDER names Jean-Marc Guettier as Division of Metabolism and Endocrinology Products acting director.

FDA Accepts sNDA for Boehringers Pradaxa

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FDA accepts for review a Boehringer Ingelheim Pharmaceuticals supplemental NDA for Pradaxa for use in patients with deep vein thro...

ACRP Praises Expedited Programs Guidance

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ACRP says an FDA draft guidance on developing and reviewing new drugs for serious or life-threatening conditions will be a valuabl...

FDA Publishes GLP Guidance for Non-clinical Studies

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FDA issues a question-and-answer guidance on the applicability of good laboratory practice regulations for non-clinical laboratory...

Novartis Asks FDA for Reclast Petition Supplement

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Novartis asks FDA to change language in a citizen petition response criticizing the company for attempting to delay an agency deci...

FDA Clears SpineGuard PediGuard Products

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FDA clears a SpineGuard 510(k) for three new products that complete its PediGuard platform of single-use drilling instruments whic...

FDA Extends Auxilium Xiaflex PDUFA Review Date

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FDA extends to 12/6 the PDUFA review goal date for Auxiliums Xiaflex to treat Peyronies disease.

Guidance on GLPs to Support Device Submissions

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Federal Register Notice: FDA releases a draft guidance: The Applicability of Good Laboratory Practice in Premarket Device Submissi...