Page 9 - Boxed Warning News Today

In patients with advanced chronic kidney disease, treatment with Prolia (denosumab) increases the risk of severe hypocalcemia, according to an updated FDA safety alert.

On January 19, 2024, the FDA announced the addition of a Boxed Warning to the labeling of denosumab (Prolia), citing evidence of an increased risk of severe hypocalcemia in patients with chronic kidney disease.

A preliminary review of side effects from popular drugs used to treat diabetes and obesity shows no link with suicidal thoughts or actions, the U.S. Food and Drug Administration said

/PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and...

NEW YORK, Jan. 12, 2024 /PRNewswire/ -- Delcath Systems, Inc. , an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announces that the...

– Newly published data highlights additional efficacy endpoints from trial – – Linaclotide is the first and only FDA-approved prescription therapy for children and adolescents aged 6-17 years...

– Expects high-single digit percentage LINZESS® EUTRx prescription demand growth in 2024 – – Expects 2024 adjusted EBITDA of greater than $150 million – ...

– Q4 DAXXIFY® volume sold up 22% over Q3, reflecting positive feedback on the product’s performance profile and the new pricing strategy. – Preliminary unaudited Q4 and full year 2023...

SAN DIEGO, Jan. 7, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. , a commercial-stage biotechnology company, today announced that it has entered into a five-year distributor partnership with...

Preliminary total 4Q and full year 2023 net product revenue of $71 million and $204 million, respectively Auvelity preliminary 4Q and full year 2023 net product sales of $49 million and $130 million,...