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Zotiraciclib granted Orphan Drug Designation by FDA and EMA
The FDA and EMA have granted Orphan Drug Designation to zotiraciclib, currently the subject of two separate Phase Ib clinical trials in glioblastoma.
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US Food and Drug Administration (FDA)
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FDA update: additional testing of ranitidine and nizatidine ordered
To further its investigation into the cause of the NDMA impurities found in ranitidine and nizatidine, the FDA has asked manufacturers of these products to expand their testing to include all lots of the medication.
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FDA updates guidance for adaptive clinical trial reporting
The US Food and Drug Administration has announced new guidance for drug applications that include results from adaptive clinical trials.
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Priority Review granted to pemigatinib for treatment of cholangiocarcinoma
The US FDA has awarded pemigatinib Priority Review, after the drug met its primary and secondary endpoints in a Phase II trial.
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The FDA has approved Exservan™ for the treatment of ALS
The FDA has granted early-action approval to Exservan for the treatment of ALS, which can be administered safely and easily without water.
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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.
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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.
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Bristol-Myers Squibb completes acquisition of Celgene
After regulatory approval, Bristol-Myers Squibb has announced its successful acquisition of Celgene, completing the merger.
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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.
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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…
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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.
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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.
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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.
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EU Marketing Authorisation submitted for Ebola vaccine regimen
Janssen has submitted two Marketing Authorisation Applications to the EMA for an investigational Ebola vaccine regimen.
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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.
