Clinical Advisor2d
FDA: Anaphylaxis Risk Prompts Boxed Warning for MS Drug
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.
MedPage Today11d
FDA Drops Testosterone's Boxed Warning on Heart Attack, Stroke Risk
A boxed warning for testosterone on major adverse cardiovascular events is out and a new blood pressure warning is in, the ...
FDA warns of health consequences amid rising nitrous oxide use
Inhaling from commercially-available nitrous oxide canisters could lead to serious harm or death, the U.S. Food and Drug ...
Healio11d
FDA recommends removing black box warning for CV risk from all testosterone product labels
The FDA has recommended several labeling changes to all approved testosterone replacement therapy products based on the ...
Lipocine announces FDA labeling changes for testosterone products
Lipocine (LPCN) announced that the FDA has recently informed sponsors of approved testosterone products about class-wide labeling changes. This ...
American Council on Science and Health4d
The FDA Finally Removes a Huge Barrier to an Effective Schizophrenia Medicine
For 35 years, the FDA has placed onerous restrictions on the only drug it has ever approved for treatment-resistant ...
Managed Healthcare Executive2d
FDA Approves First Generics of Xarelto
Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce ...
Managed Healthcare Executive3d
FDA Approves First Biosimilar of Xolair
Celltrion’s Omlyclo is interchangeable with Xolair to treat the same conditions: asthma, chronic rhinosinusitis, food allergy ...
Becker's Hospital Review11d
FDA issues class-wide labeling changes to testosterone products to include blood pressure, cardiovascular warnings
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.
Pharmabiz1d
Lipocine announces US FDA labelling changes for testosterone products
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 ...