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Conditional approval extended through December 2026 for the treatment of CID in dogs CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA’s June deadline – 51 dogs ...
EXZOLT™ CATTLE-CA1 is the first in its class and the only product conditionally approved for both the prevention and ...
Shares of Bristol Myers Squibb BMY gained 5.62% after the company announced the continuation of the phase III ADEPT-2 study ...
Bristol Myers Squibb BMY and Gilead Sciences, Inc. GILD are leading biotechnology companies with broad, diverse portfolios ...
Cytokinetics may be counting down the days until the FDA decides whether to approve its cardiovascular drug aficamten. But, for a biotech planning to commercialize its first drug—and without Big ...
Hormone therapies for menopause will no longer carry a black box warning about serious risks such as breast cancer, heart attack and stroke, the Food and Drug Administration announced Monday. In the ...
Studies in the early 2000s claimed there were major risks associated with HRT. The Food and Drug Administration said Monday it will remove the "black box" warning from hormone replacement therapy (HRT ...
Theresa Gaffney is the lead Morning Rounds writer and reports on health care, new research, and public policy, with a particular interest in mental health, gender-affirming care, and LGBTQ+ patient ...
(CNN) — Kenvue, the American company that makes Tylenol, says the US Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible ...
Tylenol maker Kenvue is calling on the Food and Drug Administration (FDA) to back off a proposed safety label change to acetaminophen after the Trump administration linked its use during pregnancy to ...