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FDA Biosimilar Testing Now Faster Than EMA

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Harvard researchers say biosimilars are often approved by FDA before they are approved in Europe.

BlueWillow to Test Intranasal Anthrax Vaccine

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FDA approves BlueWillow Biologics to conduct a Phase 1 study of its next-generation intranasal anthrax vaccine candidate BW-1010.

Public Meeting on Clinical Outcome Assessments Pilot

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FDA announces a 12/5 public meeting on its Standard Core Clinical Outcome Assessments and Endpoints Pilot Grant Program.

More FDA Regulation of Health Apps Needed: Study

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Researchers argue for expanded FDA regulation of health apps to prevent harm to consumers.

FDA Fast Track for Moderna mRNA Drug

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FDA grants Moderna a fast track designation for mRNA-3927, its investigational mRNA therapeutic for propionic acidemia.

FDA Should Regulate Genetic Tests: Disability Council

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The National Council on Disability says FDA and other federal agencies should have active oversight over prenatal genetic testing.

Provention Bio Crohns Trial Misses Endpoint

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Provention Bio says its Phase 2 PRINCE clinical trial evaluating twice-daily Crohns disease drug PRV-6527 showed that the therapy ...

3 Observations in East Marietta FDA-483

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FDA releases the FDA-483 with three observations from an inspection at East Marietta Drug Company.

FDA Denies Most of 2 Dopamine Agonist Petitions

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FDA denies most requests in Public Citizen and BioMedEcon petitions seeking stronger labeling and other actions for dopamine agoni...

Stand Down on LDT Oversight Until Congress Acts: Attorney

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Attorney Jeffrey Shapiro calls on FDA to stop all enforcement oversight of laboratory-developed tests until Congress specifically ...