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Experts Criticize New FDA Vaccine Skepticism Memo

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Leading vaccine experts sharply criticize a new FDA memo that claims ten children died after and because of receiving Covid-19 vac...

Positive Data in Stargardt Disease Pivotal Trial

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Belite Bio reports positive topline results from the global Phase 3 DRAGON trial of tinlarebant, marking the first successful pivo...

FDA Deploys New AI Tool Under Efficiency Scheme

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FDA says it has deployed advanced agentic AI capabilities to all agency employees, marking a major expansion of its artificial int...

Guidance to Update Manufacturing Standards for Medical Gases

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FDA posts a draft guidance outlining updated current good manufacturing practice standards for medical gases.

Glycar Recalls 1 Lot of SJM Pericardial Patch

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Glycar recalls (Class 1) certain batches of the SJM Pericardial Patch because affected units may fail to meet required tensile-str...

MannKind sNDA for Rapid-Acting Furoscix Autoinjector

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FDA accepts for review a MannKind supplemental NDA for its Furoscix ReadyFlow autoinjector, a fast-acting device designed to treat...

Durvalumab Regimen OKd for Gastroesophageal Cancer

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FDA approves AstraZenecas Imfinzi (durvalumab) in combination with chemotherapy as a perioperative treatment for adults with resec...

FDA Extends Review of TransCon CNP for Achondroplasia

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FDA extends by three months its review of an Ascendis Pharma NDA for TransCon CNP (navepegritide) and its use for treating childre...

9 Observations in Fareva Amboise Inspection

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FDA releases the form FDA-483 with nine observations from an inspection at Frances Fareva Amboise drug manufacturing facility.

Questions About Plausible Mechanism Pathway Continue: Attorneys

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Three Ropes & Gray attorneys outline FDAs new plausible mechanism pathway for approving personalized therapies and discuss questio...