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Priority Voucher Awarded to Genzyme

[ Price : $8.95]

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...

Info Collection Extension on Orphan Drugs

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Federal Register notice: FDA sends to OMB an information collection extension entitled Orphan Drugs 21 CFR Part 316.

Twice-Daily Weight Loss Drug Stalls: Pfizer

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Based on high discontinuation rates in a just-reported clinical trial, Pfizer says it will not advance its twice-daily weight-loss...

Epcoritamab Breakthrough Status in Follicular Lymphoma

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FDA grants Genmab a breakthrough therapy designation for epcoritamab, an investigational T-cell engaging bispecific antibody admin...