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FDA Lifts Partial Hold on Curis Leukemia Trial

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FDA lifts a partial clinical hold on the Curis Phase 1/2 trial of emavusertib in the TakeAim Leukemia study.

DTC Guidance May Signal Enforcement Shift: Attorneys

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Three Hogan Lovells attorneys say a recently finalized FDA guidance on DTC drug promotion may signal an increase in promotion enfo...

Illumina Cybersecurity Vulnerability is Class 2: FDA

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DA says a cybersecurity vulnerability in several Illumina DNA sequencing devices is Class 2.

Ipsen Planning FDA Elifibranor Application

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Ipsen says it plans to file a regulatory application with FDA for its elafibranor to treat adults with primary biliary cholangitis...

FDA Full Approval for Eisais Leqembi

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FDA converts Eisais Alzheimers drug Leqembi from accelerated to traditional approval based on the results of a confirmatory trial ...

Guidance Explains FDA 503B Wholesaling Ban

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Reed Smith attorneys analyze an FDA draft guidance on the Section 503B wholesaling prohibition.

CRL for Regeneron Aflibercept BLA

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FDA issues a complete response letter for a Regeneron BLA for aflibercept 8 mg, citing its review of a third-party filler inspecti...

FDA to Again Try to Regulate LDTs: Attorneys

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Four Sidley Austin attorneys say FDA is planning to issue a notice of proposed rulemaking to assert its authority to regulate labo...

FDA OKs SystImmune Phase 1 Lung Cancer Study

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FDA says SystImmune can start Phase 1 studies of its BL-B01D1 in some lung cancer patients.

FDA Actions Follow Advisors 88% of Time: Analysis

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Harvard Medical School researchers find FDA follows advisory committee recommendations 88% of the time, but is relying less on the...