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Roche Positive Results with Breast Cancer Drug

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Roche says it will discuss with FDA and other health authorities positive results from the Phase 3 INAVO120 study of inavolisib in...

Device Tracking Information Collection

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Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Devices; Device Tracking 21 CFR Pa...

FDA Releases Novartis Untitled Letter on GMPs

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An FDA untitled letter cautions Novartis that its manufacturing facility in Morris Plains, NJ, is deviating from current good manu...

ABK Biomedical Gets Breakthrough Status

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FDA grants ABK Biomedical a breakthrough device designation for its proposed Eye90 microspheres and its use in treating patients l...

FDA Puts Clinical Hold on Genentech MS Studies

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FDA issues a clinical hold on a Genentech multiple sclerosis clinical development program for fenebrutinib due to liver injury con...

FDA Urges ClinicalTrials.gov Compliance

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FDA warns that it is continuing to advance its compliance activities associated with required clinical trial information postings ...

Lillys Jaypirca Gains OK in Leukemia/Lymphoma

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FDA grants Eli Lilly accelerated approval for Jaypirca (pirtobrutinib) 100 mg & 50 mg tablets for treating certain adult patients ...

Pressing Need for Alternative Inspections: Researchers

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University researchers say there is a pressing need to explore alternative methods for inspecting overseas and domestic drug manuf...

Priority Voucher Awarded to Genzyme

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Federal Register notice: FDA announces that it has issued a priority review voucher to Genzyme after gaining a qualified approval ...

CBER Modifies Organization Structures in 2 Offices

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Federal Register notice: CBER modifies the organizational structures in the Office of Blood Research and Review and the Office of ...