news
FDA issues warning letter for marketing unapproved products
A warning letter has been issued by the FDA for products illegally marketed for the treatment of health conditions, including opioid withdrawal symptoms.
List view / Grid view
US Food and Drug Administration (FDA)
news
Anti-epileptic drug XCOPRI® approved by the FDA
Based on results from two global randomised studies and a large open-label safety study, XCOPRI has been approved by the FDA as a treatment for partial-onset seizures in adults.
news
Bristol-Myers Squibb completes acquisition of Celgene
After regulatory approval, Bristol-Myers Squibb has announced its successful acquisition of Celgene, completing the merger.
news
Precision Dose voluntarily recalls ranitidine oral solution
The FDA has announced that Precision Dose Inc is voluntarily recalling five lots of its ranitidine oral solution in the US.
article
Defining the ‘New World Order’ of supply chain security
Now that prominent compliance deadlines are nearing in the US, Saudi Arabia and Russia and with the Falsified Medicines Directive (FMD) now in force in Europe, what is going on around the world with serialisation? Allan Bowyer provides a rundown of current events and shares insights into the challenges businesses…
news
Ninety-seven percent response rate reported in advanced prostate cancer treatment study
A Phase III study of oral relugolix has met its primary efficacy endpoint in men with advanced prostate cancer, supporting a New Drug Application submission to the FDA.
news
Therapy approved for patients with sickle cell disease complication
Adakveo has been approved by the FDA to reduce the frequency of vaso-occlusive crisis, a painful complication of sickle cell disease.
news
Aurobindo recalls prescription and over-the-counter ranitidine
Aurobindo has recalled prescription and over-the-counter ranitidine due to the medications containing unacceptable levels of NDMA.
news
EU Marketing Authorisation submitted for Ebola vaccine regimen
Janssen has submitted two Marketing Authorisation Applications to the EMA for an investigational Ebola vaccine regimen.
news
Reblozyl approved for beta thalassaemia treatment
The US Food and Drug Administration (FDA) has granted Orphan Drug designation to Reblozyl for the treatment of anaemia in adults with beta thalassaemia.
news
Ziextenzo™ biosimilar has received approval from the FDA
The FDA has approved Sandoz's biosimilar Ziextenzo and the company now intends to launch it in the US as soon as possible this year.
news
FDA approves Helicobacter pylori infection treatment
The US FDA has granted approval for the marketing authorisation of Talicia, intended to treat adults with H. pylori infection.
news
FDA releases statement on ranitidine testing results
The FDA has issued a statement on the results from ranitidine medication testing for nitrosamines, saying that they contain no more NDMA than smoked meats.
news
Marketing authorisation recommended to be withdrawn for preterm birth drug
A vote by an FDA committee has resulted in the suggestion that marketing authorisation is revoked for preterm birth treatment Makena.
news
Relapsing multiple sclerosis drug approved by FDA
VUMERITY has been granted approved by the FDA for the treatment of relapsing forms of multiple sclerosis based on data from a New Drug Application submission.
