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2 Regenxbio Gene Therapies Get Clinical Holds

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FDA places clinical holds on two Regenxbio investigational gene therapy programs for ultra-rare pediatric diseases following the i...

Boehringer Ingelheim Reports Data on Kidney Drug

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Boehringer Ingelheim says its investigational kidney drug apecotrep reduced proteinuria by 40% compared with placebo in a Phase 2 ...

Neffy Broadcast Ad False or Misleading: OPDP

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An FDA Untitled Letter cautions ARS Pharmaceutical about false or misleading claims for its Neffy nasal spray.

Public Citizen Sues Over Drug Price Deals

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Public Citizen asks a federal court to order the Trump administration to make public the terms of drug pricing deals it signed wit...

FDA Warns HIV Testing Companies on Collection Devices

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An Akin legal update says FDAs recent issuance of Warning Letters to four direct-to-consumer testing companies over the use of una...

FDA Cites Sterile Compounding Lapses at Nubratori

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FDA cites Nubratori Inc. for multiple manufacturing and contamination-control deficiencies following a December inspection of the ...

HHS OIG Outlines Safe Harbor for DTC Drug Sales

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HHS Office of Inspector General issues new guidance clarifying when pharmaceutical manufacturers can sell prescription drugs direc...

CGMP Issues at Malaysias Fulijaya Manufacturing

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FDA warns Malaysias Fulijaya Manufacturing about CGMP violations in its production of finished drugs.

Using AI in Tumor Assessment

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A Friends of Cancer Research white paper explores the emerging role of AI-enabled tumor assessment tools and the framework needed ...

Roche Reports Positive Phase 2 Data for Obesity Drug

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Roche says its experimental dual GLP-1/GIP receptor agonist CT-388 delivered substantial and statistically significant weight loss...