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Tremfya Secures Approval for Ulcerative Colitis

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FDA approves Johnson & Johnsons Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis.

Gilead Positive on Twice-Yearly HIV Drug Data

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Gilead Sciences says data from a second pivotal Phase 3 clinical trial investigating its twice-yearly injectable lenacapavir show ...

GSK Moves mRNA Flu Vaccine to Phase 3

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GSK moves its mRNA seasonal influenza vaccine program into Phase 3 after reporting favorable Phase 2 data.

GDUFA ANDA Amendment Submissions

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FDA publishes a guidance on submitting ANDA amendments under GDUFA 3.

Regulatory Review Period for Technegas

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Federal Register notice: FDA determines the regulatory review period for Cyclomedica Australias Technegas (technetium Tc 99m-label...

Regulatory Review Period for Ztalmy

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Federal Register notice: FDA determines the regulatory review period for Marinus Pharmaceuticals Ztalmy (ganaxolone), indicated fo...

OPDP Hits AbbVie Over Serena Williams DTC Ad

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CDERs Office of Prescription Drug Promotion cites AbbVie in a just-released untitled letter over its television direct-to-consumer...

3 FDA Innovative Manufacturing Action Steps

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FDA issues a strategy document on innovative manufacturing technologies with three action steps it will take.

FDA Warns 2 Chinese Labs About Data Concerns

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FDA says it sent Warning Letters to two Chinese nonclinical labs airing concerns about data integrity.

Lawsuit Against FDA Dismissed on Ripeness Grounds

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The Washington, DC District Court dismisses a Vanda Pharmaceuticals lawsuit against FDA that challenged the agencys bioequivalence...