Emblaveo will be available in the third quarter of 2025 to treat patients with intra-abdominal infections, a common cause of sepsis in the intensive care unit.
The FDA has updated the product labeling for Xeloda and 5-FU to highlight the risks associated with dihydropyrimidine ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...
Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...
The biosimilar will be available in both subcutaneous and intravenous formulations and has nearly all the same indications as ...
The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...
FDA Approves Supernus Pharmaceuticals’ Onapgo for Managing Motor Fluctuations in Parkinson Disease
Approval of Onapgo (apomorphine hydrochloride) marks the first and only subcutaneous apomorphine infusion device for managing ...
Avtozma, the third biosimilar to Actemra, has received FDA approval for multiple inflammatory diseases and COVID-19, ...
A Dayton-area medical technology firm has recently had its AI-driven image processing and analysis technology cleared by the ...
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