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Kennedy Ally Says Makary Blocking Covid Shot Withdrawal

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Axios reports that the vice chair of the CDC Advisory Committee on Immunization Practices says the Pfizer and Moderna Covid mRNA v...

FDA Annual Report on CDRH International Harmonization

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CDRH reports on its 2025 MDUFA 5 activities to promote international harmonization.

Suggestions to Revise Hatch-Waxman Skinny Label Provisions

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A Congressional Research Service backgrounder explains options Congress could consider to resolve some issues with the skinny labe...

Summit BLA for Lung Cancer Therapy

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FDA accepts for review a Summit Therapeutics BLA seeking approval for ivonescimab in combination with chemotherapy in patients wit...

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...