WHO announces first biosimilar medicine pre-qualification
A trastuzumab biosimilar has been pre-qualified by WHO, marking its first, to improve access to the breast cancer treatment.
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A trastuzumab biosimilar has been pre-qualified by WHO, marking its first, to improve access to the breast cancer treatment.
New research has shown that intravenous injection of the BCG vaccine dramatically reduces monkey susceptibility to TB bacteria and lung inflammation.
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
US-based Novadoz Pharmaceuticals has received FDA approval for their generic version of Febuxostat 40mg and 80mg tablets.
The FDA has authorised the first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customise their diabetes management.
The UK MHRA has issued a recall of two ranitidine products from Medley Pharma as a precautionary measure due to possible contamination.
A New Drug Application has been submitted to the FDA for lonafarnib, the first-ever treatment for Progeria and Progeroid Laminopathies.
The FDA has announced that a notice of proposed rulemaking has been issued that would allow for the importation of certain prescription drugs from Canada which could lead to lower prescription drug prices.
Lumasiran, an investigational drug to treat primary hyperoxaluria type 1, has met its endpoints in clinical trials.
NICE has recommended patients in England have access to a new treatment option for treating hyperkalaemia (raised serum potassium levels) in adults.
A new pharmacovigilance document from the European Medicines Agency shows that the medicine safety system in the EU is effective.
Functional links between metabolic, cardiovascular and renal diseases, as well as a focus on digital and a personalised approach will shape diabetes drug development in 2020, says new analysis.
Dr Stephen Hahn has been voted into the role of FDA commissioner by the US Senate, taking over the role from Ned Sharpless.
The CMA has cleared the anticipated purchase of gene therapy company Spark Therapeutics by pharmaceutical company Roche Holdings.
The FDA has approved Vascepa (icosapent ethyl) as a secondary therapy to reduce cardiovascular events in adults.