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Pew: Restore FDA Oversight of Lab-developed Tests

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Pew Charitable Trusts calls on HHS to reinstate FDAs authority to require premarket reviews for laboratory-developed tests.

FDA Addressing TIRF REMS Recertification Concerns

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FDA says it is working with manufacturers of transmucosal immediate-release fentanyl products to ease provider and pharmacy recert...

FDA Priority Review for Takeda Cancer Drug NDA

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FDA grants priority review to a Takeda NDA for mobocertinib to treat some lung cancers.

Amgen Agrees to Sotorasib Dosing Trial

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Amgen agrees to an FDA-proposed post-marketing requirement to conduct a multi-center randomized clinical trial to compare the safe...

Analysis Hits National Academy cBHT Report

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A Compounding Pharmacy Foundation-funded report says FDA should ignore a National Academies report on the safety and efficacy of c...

7 Topics Discussed at MDUFA 5 Reauthorization Meeting

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The 3/17 MDUFA 5 reauthorization FDA/industry meeting covered seven topics summarized by the agency.

Panel Backs Tecentriq Continued Accelerated Approval

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An FDA advisory committee votes to recommend the continuance of Genentechs accelerated approval for Tecentriq (atezolizumab) plus ...

FDA Authorizes Parkinsons Stem Cell Trial

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FDA says Hope Biosciences Stem Cell Research Foundation can conduct a Phase 2 trial of multiple infusions of stem cells in patient...

Acceleron Failed to Submit Trial Results: FDA

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FDA says Acceleron Pharma failed to submit the required dalantercept clinical trial information to ClinicalTrials.gov.

Protalix Gets Complete Response on Fabry Therapy

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FDA issues Protalix BioTherapeutics a Complete Response Letter for its BLA seeking accelerated approval for pegunigalsidase alfa (...