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Tremfya Secures Approval for Ulcerative Colitis

[ Price : $8.95]

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.

Panel to Review ProSense Cryoablation De Novo Request

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Federal Register notice: FDA announces an 11/7 advisory committee meeting to review an IceCure Medical de novo request for its Pro...

FDA Veozah Liver Injury Warning

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FDA says it has added a Warning to labeling for Astellas Veozah about the risk of rare but serious liver injury.

Recommendations on Rare Disease Collaboration

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A new National Academies book on collaboration in rare disease drug development lists steps it recommends that FDA take.

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...