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FDA OKs AZs Tagrisso Lung Cancer Drug

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FDA approves AstraZenecas Tagrisso for some non-small cell lung cancers.

Regulatory Review Period for Ojjaara

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Ojjaara (m...

Treat all Biologics the Same: Stakeholders

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Two stakeholders say it is important that FDA state that principles in a question-and-answer guidance on pre-approval manufacturin...

House Passes Pediatric/Rare Disease Bill

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The U.S. House of Representatives passes the Give Kids a Chance Act (HR 3433) that is intended to address childhood cancer and rar...

Eisai Facility FDA-483 Out

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FDA releases the form FDA-483 issued following a 2023 inspection at an Eisai drug manufacturing facility in Gifu, Japan.

Arcutis Bio Files sNDA for Zoryve Expanded Use

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FDA accepts for review an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) foam 0.3% for treating adults and adol...

5 Observations on Hugel FDA-483

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FDA releases the form FDA-483 with five observations from a 2023 inspection at the Hugel drug substance and product manufacturing ...

Braun Introcan Deep Access Catheter Cleared

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FDA clears a B. Braun Medical 510(k) for the Introcan Safety 2 Deep Access IV Catheter.

Azurity Selling Unapproved Drugs: FDA

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FDA warns Wilmington, MA-based Azurity Pharmaceuticals it is manufacturing and marketing unapproved new drugs with CGMP violations...

Regulatory Review Period for Quviviq

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Idorsia Pharmaceuticals Quv...