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Novel drugs are new drugs never before approved or marketed in the u.s This article provides a brief overview of fda drug approvals in june 2025, highlighting new pharmaceutical stars bringing fresh hope to health and life See drugs@fda for information about all of cder’s approved drugs and biological products.
Below, pharmacy times® provides a recap of the novel retail and specialty drug approvals up until june 2025, with related coverage from the pharmacy times website. This analysis covers key drugs, modalities, and the evolving china biotech footprint. Food and drug administration (fda) provides the prescription drug user fee act date which marks the deadline by which the fda must complete its review of drug applications
Occasionally, an advisory committee meeting is convened to assess drugs or devices under consideration
Presented below is a compiled list of drugs and devices, along with the anticipated decision date currently. Up to date information on the latest fda drug approvals Includes list of most recent approvals, the conditions approved for, and the approval history. The third quarter of 2025 delivered a welcome bolus of novel fda drug approvals, with the 16 approvals in the quarter matching the 16 approvals in total in the first half of the year.
To reduce the risk of major adverse cardiovascular events (mace) (cardiovascular [cv] death, nonfatal myocardial infarction [mi], or nonfatal stroke) in adults with type 2 diabetes mellitus who are. A review of the 16 novel drugs approved by the us food and drug administration during the first half of 2025, with links to coverage from mjh life sciences publications.
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