The FDA says that even though it recognises the importance of compounded drugs, they also pose a risk to patient safety.
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GVOKE injection has received regulatory approval from the FDA for the treatment of severe hypoglycemia in patients with diabetes.
A settlement has purportedly been agreed between Purdue Pharma and 23 US states to resolve the opioid crisis case against the company.
The Operation Yellowhammer document has been published, which states that the UK will experience severe delays to the medical supply chain following a no-deal Brexit.
Tepotinib, an investigational therapy for patients with metastatic non-small cell lung cancer has been given Breakthrough Therapy Designation.
The lobbying group Innovative Medicines Canada has announced its lawsuit against plans to lower drug prices in the country.
The Kymriah (tisagenlecleucel) treatment has received a positive appraisal from the Scottish Medicines Consortium, after EMA approval last year.
Novartis reportedly knew of discrepancies in the Zolgensma data it had submitted to the FDA but delayed informing regulators so has announced alterations to its processes.
Both the intravenous and oral formulations of the antifungal candidate, fosmanogepix, have been granted Fast Track designation by the FDA.
Two Tennessee companies have been prevented from distributing drugs after a complaint they were supplying unapproved medications.
The FDA has approved the first treatment for interstitial lung disease associated with systemic sclerosis or scleroderma.
Generic treatments for blood/bone marrow disorders and acute nausea and vomiting associated with chemotherapy have gained FDA approval.
The biologic treatment ustekinumab has been granted an expanded use for ulcerative colitis within the EU.
Ahngook Pharmaceuticals reportedly held clinical trials on its employees without their consent, leading to the arrest of the company president.