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Draft Guide on Developing Early Stage Alzheimers Drugs

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FDA posts a draft guidance entitled Early Alzheimers Disease: Developing Drugs for Treatment with a focus on the ultimate goal of ...

Docket Corrected on Covid Trial Guidance

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Federal Register notice: FDA corrects a 2/22 notice announcing the availability of a final guidance on assessing Covid19-related s...

Blood Products Advisory Panel Meeting

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Federal Register notice: FDA announces a 5/9 Blood Products Advisory Committee meeting on strategies to reduce the risk of transfu...

J&J sBLA for Tremfya in Ulcerative Colitis

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Johnson & Johnson files a supplemental BLA for Tremfya (guselkumab) for treating adults with moderately to severely active ulcerat...

Panel Backs Lumisight Breast Surgical Imaging

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An FDA advisory committee votes 16-2 in support of approving a Lumicell NDA for Lumisight (pegulicianine), an optical imaging agen...

Getinge Vasoview Hemopro 3 Cleared

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FDA clears a Getinge 510(k) for the Vasoview Hemopro 3, a third-generation endoscopic vessel harvesting device.

Wegovy OKd for Reducing Cardiovascular Death

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FDA approves Novo Nordisks weight loss drug Wegovy (semaglutide) injection for reducing the risk of cardiovascular death, heart at...

FDA Delays Lilly Alzheimers Drug for Panel Review

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FDA pushes back its review decision on Eli Lillys experimental Alzheimers drug donanemab by requiring an advisory committee to dis...

Amylyx Mulls Withdrawing ALS Drug

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Amylyx Pharmaceuticals considers withdrawing its amyotrophic lateral sclerosis drug Relyvrio (sodium phenylbutyrate and taurursodi...

Lilly Requests EUA Revocation for Covid Combo

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Federal Register notice: FDA revokes an Eli Lilly emergency use authorization for bamlanivimab and etesevimab administered togethe...