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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 ...

Travere sNDA for Filspari Full Approval

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FDA tells Travere Therapeutics that data appear to support a supplemental NDA to convert the companys accelerated approval to full...

J&J Breakthrough Status on Bladder Cancer Drug

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FDA awards Johnson & Johnson a breakthrough therapy designation for TAR-200 for treating certain patients with Bacillus Calmette-G...

Lawmakers Press Califf on OTC Decongestant

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A House of Representatives subcommittee asks FDA commissioner Robert Califf for a staff-level briefing on why it took so long for ...

CDER Cleaning House on Dormant Petitions

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CDER says it is seeking to withdraw unresolved citizen petitions that have lingered for more than five years at the agency without...

Eitan Medical Recall Infusion Pumps

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Eitan Medical recalls its Sapphire MT Infusion Pump, Sapphire Epidural Infusion Pump, and Sapphire Plus Infusion Pump due to softw...