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Fast Track Status Given to Synta Lung Cancer Drug

[ Price : $8.95]

FDA grants Synta Pharmaceuticals a fast track designation for ganetespib, a heat shock protein 90 (Hsp90) inhibitor drug candidate...

Bioanalytical Method Validation Guidance

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FDA issues a draft guidance on developing bioanalytical method validation information for human and animal drugs.

BMS Yervoy Misses Phase 3 Endpoint

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Bristol-Myers Squibb says a Phase 3 trial of its Yervoy in treating advanced prostate cancer failed to meet its primary endpoint o...

United Therapeutics Re-files NDA for Treprostinil Diolamine

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United Therapeutics resubmits an NDA for treprostinil diolamine extended release tablets for treating pulmonary arterial hypertens...

OvaScience Suspending Augment Enrollment in U.S.

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OvaScience says it is suspending U.S. enrollment of its Augment in vitro fertilization egg enhancement product while it discusses ...

FDA Extends Comments on Cigarette/Menthol Regulation

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Federal Register Advance notice of proposed rulemaking: FDA extends the comment period to 11/22 on a 7/24 request for comments on ...

Woodcock Praises GDUFA Staff Work

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CDER director Janet Woodcock says the GDUFA Human Capital Team has hired and trained 234 new employees for GDUFA implementation.

Temple Says CDER Tougher on Stupid Trial Subpopulation Exclusions

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CDER deputy director for clinical science Bob Temple says drug reviewers are becoming more aggressive with drug sponsors and their...

CDER is Enthusiastic About Patient-reported Outcomes: Temple

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Addressing criticism that patients subjective self-assessments have been identified as generally not reliable or informative, CDER...

Inspection Guidance Leaves Questions Unanswered: Lawyers

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Alston & Bird attorneys say an FDA draft guidance on inspection refusals raises additional questions and potential areas of misund...