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FDA appoints another new CDER director, selecting Dr Tracy Beth Høeg
She will become the fifth leader at the Center, following the surprise retirement decision by her soon-to-be predecessor Richard Pazdur.
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U.S. Food and Drug Administration (FDA)
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FDA aims to advance non-addictive opioid alternatives for acute pain management
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.
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Metastatic melanoma treatment gets Breakthrough Therapy Designation
Breakthrough Therapy Designation has been granted for investigational agent bempegaldesleukin in combination with nivolumab.
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Nubeqa® approved by the US Food and Drug Administration
FDA approves Nubeqa (darolutamide) as a new treatment for men with non-metastatic castration-resistant prostate cancer.
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Two lots of Kogenate® recalled due to mislabelling
Two lots of Kogenate® FS vials actually contain the FVIII hemophilia A treatment, Jivi®.
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Warning issued to company for using unfounded CBD treatment claims
FDA issues warning to a company that claimed its CBD products can be used to treat cancer and Alzheimer's disease.
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Sickle cell drug wins Priority Review by the FDA
The US Food and Drug Administration (FDA) has given an investigational sickle cell medicine, crizanlizumab (SEG101), Priority Review.
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FDA approves novel treatments for heart disease
The US Food and Drug Administration (FDA) has approved new treatments for heart disease caused by ATTR-CM in adults.
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Five more countries to join EMA-FDA mutual recognition
The US FDA has announced that it will confirm the capability of five more countries to carry out good manufacturing practice (GMP)...
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FDA approves new dosage strength of buprenorphine and naloxone
The US FDA has announced a new dosage strength for Cassipa sublingual film for the maintenance treatment of opioid dependence...
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FDA approves Aristada Inito for the initiation of Aristada for schizophrenia
Novel regimen enables physicians to fully dose up to two months of Aristada treatment on day one...
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FDA approves Epidiolex derived from marijuana, for severe epilepsy
The FDA has approved Epidiolex oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy...
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FDA approves automated insulin delivery and monitoring system for paediatric patients
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...
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FDA approves first generic versions of Suboxone for opioid dependence
The FDA has approved the first generic versions of Suboxone sublingual film for the treatment of opioid dependence...
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FDA approves first biosimilar to Neulasta
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.
