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Cycles Harliku Approved for Alkaptonuria

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FDA approves a Cycle Pharmaceuticals NDA for Harliku (nitisinone) tablets for reducing urine homogentisic acid in adult patients w...

Is FDA Going After RUO Diagnostics?

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Two SheppardMullin attorneys say it remains to be seen whether a recent FDA Warning Letter to DRG Instruments about selling resear...

FDA Halts Some Cell Clinical Trials

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FDA says it is reviewing all clinical trials that rely on a Biden administration exemption that allowed sensitive biological mater...

Top 2 FDA Cell/Gene Therapies Officials Pushed Out

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FDA places CBER Office of Therapeutic Products director Nicole Verdun and her deputy Rachael Anatol on administrative leave in the...

Securing Technology, Equipment Report

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The FDA Office of Regulatory and Emerging Science publishes a report describing agency efforts to research cybersecurity and advan...

Bavarian Nordic Sells Priority Voucher for $160 Million

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Bavarian Nordic enters into an agreement to sell for $160 million a priority review voucher that was awarded for gaining approval ...

Court OKs FDA Ozempic Drug Shortage Action

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A Texas federal judge rules FDA acted properly in removing Novo Nordisks Ozempic and Wegovy from its drug shortage list.

Gottlieb Believes CBER Will Probe Sarepta Approval

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Former FDA commissioner Scott Gottlieb expects FDA will reevaluate Sareptas approval of Duchenne muscular dystrophy gene therapy E...

FDA Webview Closed on Juneteenth (6/19)

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FDA Webview closes and will not be publishing on 6/19 in recognition of the U.S. federal holiday, Juneteenth.

FDA Warns on Transderm Scop Heat Complications

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FDA warns that Baxter Healthcares antinausea patch Transderm Scop (scopolamine transdermal system) can increase body temperature a...