European Pharmaceutical Review

AUGUST 4, 2023

There are at present, nine US Food and Drug Administration (FDA)-approved agents, GlobalData stated. billion in 2022, a product that was launched in 2002. This has developed following numerous adalimumab biosimilar offerings being brought to market. Worldwide sales for Humira peaked at $21.2

Marketing 97

Marketing Food and Drug Administration Food Medicine 97

Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. The drug is currently under review in Australia, the EU and Switzerland.

FDA 97

FDA Food and Drug Administration Food Pharmaceutical 97

European Pharmaceutical Review

FEBRUARY 14, 2023

A key benefit of mRNA therapeutics is that manufacturing time is fast compared to antibodies or protein-based drugs. The research also identified other challenges for mRNA therapeutics’ delivery , including their high cost, susceptibility to degradation by ribonucleases and limitations with drug delivery systems.

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Food and Drug Administration Medicine Safety Consulting 105

pharmaphorum

SEPTEMBER 13, 2022

Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001. 2002 – Emergence of CAR-T therapy. 2002 – Emergence of CAR-T therapy. However, the first generation of CAR T-cells proved to be clinically ineffective.

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Food and Drug Administration Patients Engineering Physicians 98

European Pharmaceutical Review

NOVEMBER 15, 2022

Lorrie Vuolo-Schuessler has been involved with ISPE and the GAMP © Community of Practice leadership since 2002 and is currently Chair of the GAMP Americas Steering Committee and a member of the GAMP Global Leadership Team. FDA, Computer Software Assurance for Production and Quality System Software – Draft Guidance. FDA, 2022. .

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Manufacturing Pharma Food and Drug Administration Safety 98

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

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Food and Drug Administration Safety Patients Leads 97

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. References Drugs@FDA: FDA-Approved Drugs.

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Food and Drug Administration Medicine FDA Marketing 52