46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it ...

Potential blockbusters and root-cause treatments from Eli Lilly, Merck, Takeda and others could get a regulatory nod this ...

The US saw several new and expanded FDA indications this year. The top 5 most-read FDA approvals on AJMC.com included 4 novel ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

Section deals with the comprehensive list of drugs approved by FDA in 2023. Drug information includes the drug name and indication of use.

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. For the first time, a generic GLP-1 has been approved by ...

In this study, researchers sought to determine the impact of the FDA’s Accelerated Approval pathway among patients with solid tumors.

Drugmaker Novo Nordisk said the prescription medicine can be found at a range of pharmacies, including CVS and Costco, as ...

The Food and Drug Administration (FDA) approved a generic version of the abortion pill mifepristone in October, making chemical abortion more affordable and accessible to pregnant women who wish to ...

In the midst of the rising popularity of glucagon-like peptide-1 receptor agonists (GLP-1RAs), and their compounded versions, the US Food and Drug Administration (FDA) has been stepping up its efforts ...