pharmaphorum

OCTOBER 1, 2020

Shares in US biotech CTI BioPharma have shot up after the FDA agreed to an accelerated review early next year of its lead drug pacritinib for low blood platelets (thrombocytopenia) caused by myelofibrosis. The post CTI wins over FDA to claim early review of myelofibrosis drug appeared first on. Jakafi had sales of more than $1.1

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The FDA Law Blog

NOVEMBER 22, 2022

Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region. All records required under the final rule must be made available to FDA within 24 hours after a request is made. coli contamination.

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The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA further retained some definitions in the QSMR. Notably, Part 820 will look different. Revised § 820.3

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pharmaphorum

AUGUST 6, 2020

The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. The post FDA approves GSK’s Blenrep for advanced multiple myeloma appeared first on. Keratopathy leading to treatment discontinuation affected 2.1% of patients in the cohort.

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European Pharmaceutical Review

SEPTEMBER 26, 2023

This recent decision by the EC follows approval of Tyruko ® (natalizumab) by the US Food and Drug Administration (FDA) last month for the same indication. The regulatory package submitted to the EC included evidence derived extensive analytical characterisation. The site is planned to be completed by 2026.

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