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FDA Cites Cancer Drug Television Ad

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FDA issues an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug...

Ways for FDA to Modernize Biotech Regulation

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The National Security Commission on Emerging Biotechnology recommends 22 policy actions in five key areas to modernize FDA medical...

PharmaEssentia Besremi sBLA for Essential Thrombocythemia.

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FDA accepts for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi to include ...

Pazdur Warns About Political Interference, Upheaval At FDA

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Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are erod...

FDA Extends Review for Filspari in Kidney Disease

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FDA extends by three months its review of a Travere Therapeutics supplemental NDA for Filspari in focal segmental glomeruloscleros...

Baxter Class 1 Recall of Sigma Infusion Pumps

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FDA classifies as Class 1 a recall of certain Sigma Spectrum infusion pumps made by Baxter, warning that continued use of the affe...

35 Items on CDER CY2026 Guidance Agenda

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CBER says it expects to publish 35 draft and final guidances this calendar year, including several likely-to-be controversial draf...

Remove Suicide Warning from GLP-1 Drugs: FDA

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FDA says Novo Nordisk and Lilly should remove statements about the potential for suicidal ideation and behavior from labeling for ...

Flexible Regulatory Approaches for Cell/Gene Therapy CMC Info

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FDA articulates a flexible regulatory approach to chemistry, manufacturing and controls for cell and gene therapies, a move the ag...

Orphan Status for Novita Pancreatic Cancer Drug

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FDA grants Novita Pharmaceuticals an orphan drug designation for its experimental cancer drug NP-G2-044 for treating pancreatic ca...