Reports of anaphylaxis associated with the use of glatiramer acetate have prompted the Food and Drug Administration (FDA) to add a Boxed Warning to the prescribing information.
A boxed warning for testosterone on major adverse cardiovascular events is out and a new blood pressure warning is in, the ...
Inhaling from commercially-available nitrous oxide canisters could lead to serious harm or death, the U.S. Food and Drug ...
Do: Respond within 15 business days of the original letter and be specific in that response. “It’s important to critically ...
The FDA has recommended several labeling changes to all approved testosterone replacement therapy products based on the ...
Lipocine (LPCN) announced that the FDA has recently informed sponsors of approved testosterone products about class-wide labeling changes. This ...
Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce ...
Celltrion’s Omlyclo is interchangeable with Xolair to treat the same conditions: asthma, chronic rhinosinusitis, food allergy ...
The FDA has announced new labeling changes for all testosterone products following a review of clinical trial data, including a TRAVERSE study and postmarket ambulatory blood pressure studies.
Lipocine announces US FDA labelling changes for testosterone products: Salt Lake City Thursday, March 13, 2025, 16:00 Hrs [IST] Lipocine Inc., a biopharmaceutical company leveragi ...
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