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 ...

Do: Respond within 15 business days of the original letter and be specific in that response. “It’s important to critically ...

“Abrupt” reductions in antidepressant treatment “ranging from 20 percent to 50 percent” Increases in psychotropic drug ...

Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and ...

The FDA has recommended several labeling changes to all approved testosterone replacement therapy products based on the ...

The TRAVERSE trial, a large-scale clinical study with over 5,000 patients, published in 2023, concluded that TRT does not increase the risk of adverse cardiovascular outcomes in men with hypogonadism.

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

Benzonatate should not be combined with alcohol, sleep aids, or opioids. Certain anesthetics and mental health medications can also interact with benzonatate.

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.

Shortly after making an M&A play to break into the CDMO business, Granules’ manufacturing bona fides have come under fire in ...

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 ...