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FDA Urges Trial Sponsors to Disclose Missing Clinical Study Results

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FDA has issued a reminder to more than 2,200 clinical trial sponsors and researchers, urging them to comply with federal requireme...

Greater Alignment Needed for External Control Arms: Stakeholders

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A panel of industry leaders, policy experts, and FDA say broader adoption of external control arms in oncology drug development wi...

FDA Flags Quality Control Lapses at Indian API Maker

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FDA cites an Indian drug manufacturer for deficiencies in laboratory testing and quality control procedures following an inspectio...

Eye Doctor Emerges as Contender for CBER Head

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FDA is reportedly considering ophthalmologist and biotech executive Houman Hemmati as CBERs next director.

Daiichi Sankyo, Merck Lung Cancer Therapy Gets Priority Review

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FDA accepts for priority review a Daiichi Sankyo and Merck BLA for ifinatamab deruxtecan, an investigational therapy for patients ...

Pfizers Adcetris Social Media Ads are Misleading: FDA

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FDA cites Pfizer over social media promotions for its cancer drug Adcetris, stating that certain Facebook advertisements are false...

Cato Institute urges FDA overhaul to keep pace with AI

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A new policy analysis from the Cato Institute urges FDA to modernize its regulatory framework for artificial intelligence in healt...

FDA rejects Replimune Melanoma Therapy Again

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FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination w...

Alert on Cook Medical Sizing Catheters

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FDA issues an early alert regarding a potential safety issue affecting certain sizing catheters manufactured by Cook Medical.

Rep. Auchincloss Seeks FDA Whistleblowers

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Representative Jake Auchincloss (D-MA) urges FDA whistleblowers to come forward to disclose instances of wrongdoing by agency mana...