The outcomes of a successful pre-NDA meeting with the FDA are: As agreed with the FDA, the rolling NDA submission will commence in December 2025, targeting a complete NDA submission in early 2026 and ...
It was my cool, hipster hair stylist, Dylan, who first told me that Amazons—you know, that empire of legendary women warriors ...
Levofloxacin-induced myopathy is a relatively under-recognized adverse effect. Here, we present a case of myopathy affecting ...
If you think your pharmacist can’t offer much guidance on your prescriptions, think again. While they don’t attend medical ...
Last month, Trump warned of a link between autism and acetaminophen use in pregnancy, going against advice from medical ...
Kenvue, the American company that makes Tylenol, says the US Food and Drug Administration should not make proposed changes to ...
Kenvue has urged U.S. regulators to reject a request seeking autism warning label on its popular over-the-counter pain ...
Kenvue urged U.S. regulators to deny a request warning against Tylenol’s use during pregnancy, laying out the most detailed ...
A petition asks the FDA to change the label to better reflect research about a possible connection between acetaminophen use ...
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