FDA emphasises need for adverse event reporting of compounded drugs
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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FDA grants regulatory approval for hypoglycemia treatment
GVOKE injection has received regulatory approval from the FDA for the treatment of severe hypoglycemia in patients with diabetes.
Germany imports largest ever shipment of EU medicinal cannabis
An import of medicinal cannabis from Portugal to Germany signifies the largest quantity ever moved within the EU, highlighting a surge in the medicinal cannabis products market.
UK to launch seven data hubs to garner insights for improved healthcare
The seven centres will aid disease research and clinical development, improving access to patient data for studies.
Purdue reported to reach tentative agreement over opioid trial
A settlement has purportedly been agreed between Purdue Pharma and 23 US states to resolve the opioid crisis case against the company.
Blockchain technology in healthcare market to hit $1.6bn by 2025
According to a new report, blockchain technology in the healthcare market size is set to increase exponentially.
Operation Yellowhammer file confirms drug shortages after no-deal Brexit
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.
FDA grants Orphan Drug Designation to sotatercept
Orphan Drug Designation has been given to sotatercept for the treatment of patients with pulmonary arterial hypertension.
Metastatic NSCLC therapy, tepotinib, given Breakthrough Designation
Tepotinib, an investigational therapy for patients with metastatic non-small cell lung cancer has been given Breakthrough Therapy Designation.
Innovative Medicines Canada files against federal plans
The lobbying group Innovative Medicines Canada has announced its lawsuit against plans to lower drug prices in the country.
Bacteriostatic Water recalled due to a potential lack of sterility assurance
Bacteriostatic Water is being recalled because of a lack of sterilisation confirmation for some vials.
Global LC-MS market to exhibit CAGR of 6.9 percent
Research has found that the worldwide LC-MS market will be worth $2750 million by the end of the forecast period in 2024.
Scottish Medicines Consortium approves Kymriah® CAR-T therapy
The Kymriah (tisagenlecleucel) treatment has received a positive appraisal from the Scottish Medicines Consortium, after EMA approval last year.
CEO of Novartis pledges to speed data integrity disclosures
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.
Fast Track designation granted to fosmanogepix for seven indications
Both the intravenous and oral formulations of the antifungal candidate, fosmanogepix, have been granted Fast Track designation by the FDA.
