The US Food and Drug Administration has awarded APR-TD011 Orphan Drug Designation, for the treatment of a rare disease.
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The first three applications for generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of MS have been approved.
The FDA and EMA have granted Orphan Drug Designation to zotiraciclib, currently the subject of two separate Phase Ib clinical trials in glioblastoma.
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.
The US Food and Drug Administration has announced new guidance for drug applications that include results from adaptive clinical trials.
The US FDA has awarded pemigatinib Priority Review, after the drug met its primary and secondary endpoints in a Phase II trial.
The FDA has granted early-action approval to Exservan for the treatment of ALS, which can be administered safely and easily without water.
A warning letter has been issued by the FDA for products illegally marketed for the treatment of health conditions, including opioid withdrawal symptoms.
After regulatory approval, Bristol-Myers Squibb has announced its successful acquisition of Celgene, completing the merger.
The FDA has announced that Precision Dose Inc is voluntarily recalling five lots of its ranitidine oral solution in the US.
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…
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.
Adakveo has been approved by the FDA to reduce the frequency of vaso-occlusive crisis, a painful complication of sickle cell disease.
Aurobindo has recalled prescription and over-the-counter ranitidine due to the medications containing unacceptable levels of NDMA.