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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...

DTC Ads Kennedys Next Target?

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Bloomberg News says President Trump and HHS secretary Kennedy are looking at policies that they hope would drive drug companies aw...

FDA Approves Gileads Yeztugo for HIV Prevention

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FDA approves Gileads Yeztugo as the only HIV pre-exposure prophylaxis twice-yearly option.

GDUFA Post-Warning Letter Meeting Guidance

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FDA publishes a guidance on its implementation of the post-Warning Letter meeting established in the GDUFA 3 commitment letter to ...

Open Bipartisan Probe of RFK Vaccine Plans: Pallone

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House Energy and Commerce Committee ranking Democrat Frank Pallone calls for a bipartisan committee investigation of HHS secretary...