Here in the USA, we have lived with the confidence that the medications sold over the counter, by prescription or ...
The Trump administration is proposing changes to Food and Drug Administration guidelines that would make it less expensive ...
The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative ...
GlobalData on MSN
FDA looks to simplify biosimilar development with new draft guidance
The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...
5don MSN
FDA to streamline approvals for generic biological drugs in latest move targeting health costs
The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex ...
The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and ...
The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for ...
Biologic medications, while accounting for only 5% of U.S. prescriptions, represent 51% of total drug spending in 2024. Despite FDA-approved biosimilars being as safe and effective as their branded ...
The Chosun Ilbo on MSN
Personalized Gene Therapy Saves Baby, Speeds FDA Approval
Baby Muldoon, born with a rare genetic disorder, could not eliminate nitrogen compounds in the body, causing toxic ammonia to ...
The U.S. Food and Drug Administration announced it will relax certain rules for approving low-cost versions of some ...
Developers of biosimilars, medicines that are near-identical copies of biologic drugs, will no longer be required to conduct clinical trials to prove effectiveness.
The FDA enlisted British drugmaker GSK to help it fast-track approval of leucovorin to treat an autism-related disorder.
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