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It is paramount that manufacturers and their suppliers ensure that…
It is paramount that manufacturers and their suppliers ensure that the quality of compounded drugs are high, by preventing risks of contamination...
Dr Scott Gottlieb highlighted how brand reference drug companies voluntarily…
Dr Scott Gottlieb highlighted how brand reference drug companies voluntarily withdraw their marketing applications and stopped updating their labelling...
US FDA commissioner has announced steps to modernise the drug…
US FDA commissioner has announced steps to modernise the drug development process to improve efficiency and promote innovation...
The FDA has updated its Opioid Analgesic REMS to ensure…
The FDA has updated its Opioid Analgesic REMS to ensure caregivers and patients use opioids effectively...
The US FDA has announced a new dosage strength for…
The US FDA has announced a new dosage strength for Cassipa sublingual film for the maintenance treatment of opioid dependence...
Some drugs with active ingredient valsartan have been recalled due…
Some drugs with active ingredient valsartan have been recalled due to presence of impurity NMDA...
The US Food and Drug Administration has approved TPOXX (tecovirimat),…
The US Food and Drug Administration has approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox...
The FDA has approved Epidiolex oral solution for the treatment…
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…
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…
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)…
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.
U.S. District Judge Robert J. Shelby entered a consent decree…
U.S. District Judge Robert J. Shelby entered a consent decree of permanent injunction between the United States and Isomeric Pharmacy Solutions...
The FDA has announced its latest action to encourage and…
The FDA has announced its latest action to encourage and support the development of treatment options for people with opioid use disorder...
FDA acts to protect children from serious risks of opioid…
FDA acts to protect children from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labelling to limit paediatrics use...
The FDA has approved Admelog, a short-acting insulin indicated to…
The FDA has approved Admelog, a short-acting insulin indicated to improve control in blood sugar levels in diabetes...
