The U.S. Food and Drug Administration (FDA) has granted full approval of Laverdia, a drug to treat dogs with lymphoma, a type ...

Optum notable drugs nearing FDA approval include Anaphylm, Sotyktu, and insulin icodec with decisions expected early 2026.

Federal regulators are telling drugmakers to remove label warnings about potential suicidal thoughts and behaviors from their ...

FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...

Dr. Soon-Shiong is hopeful the Saudi Arabian FDA's approval of his cancer therapy drug, Anktiva, will lead to widespread ...

While the FDA came out on top over the EMA in terms of approvals, both agencies greenlighted fewer new drugs than in 2024.

Jefferies analysts envision a steady launch curve that could ultimately drive meaningful sales from people who are ...

The FDA approved copper histidinate (Zycubo) as the first treatment for Menkes disease in pediatric patients, the agency ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...

The FDA has granted full approval to verdinexor tablets (Laverdia; Anivive Lifesciences) for the treatment of dogs with lymphoma. The approval gives veterinarians a promising new oral avenue for ...

Officials with the FDA have approved the first generic robenacoxib tablets for the control of postoperative pain and ...