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FDA OKs New Schizophrenia Drug

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FDA approves Bristol-Myers Squibbs Cobenfy (xanomeline and trospium chloride) capsules for treating schizophrenia in adults.

Advisory Committee Consumer Reps Sought

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Federal Register notice: FDA seeks consumer organizations interested in participating in the selection process for voting or nonvo...

OMB Clears 4 Informaton Collections

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Federal Register notice: FDA announces that four information collections have been approved by OMB.

Appeals Court Gives FDA a Win on Stem Cells

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The U.S. 9th Circuit Court of Appeals reverses an earlier California lower court decision that ruled a stem cell treatment firm is...

FDA-passed Parkinsons Drug Part of Falsified Research Probe

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An investigation by the journal Science questions the data behind a Parkinsons drug under development by Prothena and based on fal...

FDA Full Approval for Lillys Retevmo

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FDA grants Eli Lilly full approval for Retevmo (selpercatinib) for certain adult and pediatric patients two years of age and older...

AbbVie BLA for Teliso-V in Lung Cancer

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AbbVie files a BLA seeking accelerated approval for Teliso-V (telisotuzumab vedotin) and its use in certain adult patients with pr...

AbbVie Parkinsons Trial Meets Endpoints

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AbbVie says a pivotal Phase 3 (TEMPO-1) trial for tavapadon in early Parkinsons disease met its primary and secondary endpoints.

FDA Proposal to Reclassify HBV Assays

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Federal Register notice: FDA proposes to reclassify qualitative hepatitis B virus (HBV) antigen assays, qualitative and quantitati...

3 FDA Clinical Trial Guidances Analyzed

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Four Ropes & Gray attorneys identify the key provisions in three new FDA clinical trial modernization guidances.