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The U.S. Food and Drug Administration (FDA) has taken new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new addiction.
Breakthrough Therapy Designation has been granted for investigational agent bempegaldesleukin in combination with nivolumab.
FDA approves Nubeqa (darolutamide) as a new treatment for men with non-metastatic castration-resistant prostate cancer.
Two lots of Kogenate® FS vials actually contain the FVIII hemophilia A treatment, Jivi®.
FDA issues warning to a company that claimed its CBD products can be used to treat cancer and Alzheimer's disease.
The US Food and Drug Administration (FDA) has given an investigational sickle cell medicine, crizanlizumab (SEG101), Priority Review.
The US Food and Drug Administration (FDA) has approved new treatments for heart disease caused by ATTR-CM in adults.
The US FDA has announced that it will confirm the capability of five more countries to carry out good manufacturing practice (GMP)...
The US FDA has announced a new dosage strength for Cassipa sublingual film for the maintenance treatment of opioid dependence...
Novel regimen enables physicians to fully dose up to two months of Aristada treatment on day one...
The FDA has approved Epidiolex oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy...
The FDA has approved a diabetes management device that is intended to automatically monitor glucose and provide appropriate basal insulin doses with little or no input from the user...
The FDA has approved the first generic versions of Suboxone sublingual film for the treatment of opioid dependence...
The U.S. Food and Drug Administration has approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment.
Novel enzyme therapy for adults with PKU who have uncontrolled blood phenylalanine concentrations with current treatment...
