The U.S. Food and Drug Administration (FDA) has issued new draft guidance that mandates the inclusion of overall survival (OS) data in all randomized clinical trials...
The U.S. Food and Drug Administration (FDA) has issued new draft guidance requiring that overall survival (OS) data be included in all randomized cancer drug clinical...
Frozen shrimp sold in the United States has been recalled due to potential contamination with a radioactive isotope. The Food and Drug Administration (FDA) issued notifications...
AbbVie has announced that its drug, Rinvoq, successfully met the primary endpoint in a second Phase 3 clinical trial aimed at treating severe alopecia areata. This...
Sarepta Therapeutics has successfully refinanced its debt, providing the biotech firm with a stronger financial footing as it navigates a complex regulatory landscape. This move comes...
The Food and Drug Administration (FDA) has confirmed the recall of over 88,000 bottles of two types of blood pressure and heart medications due to concerns...
The Food and Drug Administration (FDA) has confirmed the recall of over 88,000 bottles of carvedilol tablets, a medication commonly prescribed for high blood pressure and...
The Food and Drug Administration (FDA) has granted accelerated approval for the weight loss medication Wegovy to treat a serious liver condition known as noncirrhotic metabolic...
Tandem Diabetes Care, Inc., based in San Diego, has initiated a voluntary recall of its t:slim X2 insulin pumps following reports of malfunctions that have resulted...
Neurizon Therapeutics has announced a delay in the decision regarding its Investigational New Drug (IND) application, attributing the setback to “strain” within the U.S. Food and...
