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Securing Technology, Equipment Report

[ Price : $8.95]

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

Dupixent Approved for Bullous Pemphigoid

[ Price : $8.95]

FDA has approved Sanofi and Regenerons Dupixent (dupilumab) for treating adult patients with bullous pemphigoid that mainly affect...

Monjuvi Approved for Follicular Lymphoma

[ Price : $8.95]

FDA approves Incytes Monjuvi (tafasitamab-cxix) in combination with lenalidomide and rituximab for treating adults with relapsed o...

FDA Clears DeepEcho AI Fetal Ultrasound

[ Price : $8.95]

FDA clears a DeepEcho 510(k) for its artificial intelligence-based fetal ultrasound analysis platform.

Cycles Harliku Approved for Alkaptonuria

[ Price : $8.95]

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

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...