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Woodcock Heads to Hill Hearing on FDA Budget

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FDA acting commissioner Janet Woodcock prepares to testify 6/10 before the Senate Subcommittee on Agriculture, Rural Development, ...

Edwards Finger Cuff Cleared for Hypotension Predictor

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FDA clears an Edwards Lifesciences 510(k) for its Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuf...

Novo Nordisk Drug Approved for Weight Loss

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FDA approves a Novo Nordisk NDA for Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in overweigh...

FDA Approves Smallpox Drug

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FDA approves a Chimerix NDA for Tembexa (brincidofovir) for treating smallpox.

Clinical Hold on Ortho Regenerative Rotator Cuff Trial

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FDA issues a clinical hold on a Ortho Regenerative Technologies Phase 1-2 clinical trial for Ortho-R, a drug/biologic combination ...

New FDA Drug Supply Chain Guidances

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FDA releases two final and two draft guidances to help stakeholders implement provisions of the Drug Supply Chain Security Act.

Abernethy Lands at Verily to Lead RWE Effort

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Former FDA principal deputy commissioner Amy Abernethy joins Alphabets Verily as president of its clinical research business, wher...

Guide on Enteral Feeding Drug Products

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Federal Register notice: FDA releases a draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro...

FDA Accepts PharmaEssentia BLA Resubmission for PV Treatment

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FDA assigns a PDUFA action date of 11/13 for a PharmaEssentia BLA for ropeginterferon alfa-2b-njft to treat polycythemia vera, a r...

FDA Cautions Patients, Consumers on Regenerative Products

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FDA issues a warning to patients and consumers about regenerative medicine therapies.