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Cubist Ends Phase 2 Program on Safety Concerns

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Cubist Pharmaceuticals closes enrollment in its CB-500,929 (ecallantide) Phase 2 program, an investigational therapy for reducing ...

FDA OKs 2 Tris Pharma Anti-hypertensives

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FDA approves two Tris Pharma NDAs for once-daily clonidine extended-release suspension and tablets to treat hypertension.

Advisors Back Novartis Kidney Transplant Drug

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Members of FDAs Cardiovascular and Renal Drugs Advisory Committee say that Novartis Certican appears to be safe and effective in p...

FDA Says Silenor NDA Cant be Approved

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FDA again says that Somaxons NDA for Silenor to treat insomnia cannot be approved.

FDA Social Media Hearing Transcripts Available

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FDA releases its transcripts of last months two-day public hearing on social media.

Aeterna Zentaris Prostate Drug Trial Misses Mark

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Aeterna Zentaris says that its benign prostatic hyperplasia drug filed to meet its endpoint in a 39-site European Phase 3 trial.

Guidance on Therapeutic Protein Assays

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Federal Register Notice: FDA releases a draft guidance on assay development for immunogenicity testing of therapeutic proteins.

CDER Making Stealth Comparative Effectiveness Decisions: Pendergast.

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Former FDA deputy commissioner Mary Pendergast warns that CDER is making stealth comparative effectiveness decisions on standard N...

CGMP Violations Found in Providence Inspection

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FDAs Denver District Office warns Provident Pharmaceuticals about CGMP violations and manufacture of unapproved drugs.

FDA Says Modified Steris System 1 Processor Unapproved

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FDA says Steris has failed to transition customers to approved substitutes for its modified and unapproved SS1 Processor used to s...