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Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. The company plans to submit an MAA to the EMA in H1 this year.

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FDA proposes new model for easy-to-understand prescription guides

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The FDA said that the proposed revamp should help limit preventable adverse drug reactions and improve health outcomes.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% The drug was approved to treat type 2 diabetes mellitus in May. The same can be said for the US. had severe obesity.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% The drug was approved to treat type 2 diabetes mellitus in May. The same can be said for the US. had severe obesity.

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