Pharmaceutical Technology

JANUARY 22, 2023

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.

FDA 126

FDA Safety Patients Pharmaceutical 126

Pharmaceutical Technology

MAY 31, 2023

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.

Prescription 52

Prescription FDA Food and Drug Administration Medical 52

Pharmaceutical Technology

NOVEMBER 30, 2022

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.

Medical 105

Medical Manufacturing Insurance Side effects 105

Pharmaceutical Technology

NOVEMBER 30, 2022

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.

Medical 98

Medical Manufacturing Insurance Side effects 98