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The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.
The US FDA will fund a research project using Raman spectroscopy and mass spectrometry to study drug delivery via the skin.
A report has suggested that number of Orphan Drug Designations in both the US and Europe is declining, possibly due to prices and political changes.
The FDA has released a statement, announcing that the US is experiencing its first shortage as a result of the effects of COVID-19.
Advil Dual Action is the first FDA-approved an over-the-counter ibuprofen and acetaminophen combination, backed up with data from several clinical trials proving its efficacy.
Ranitidine tablets have been recalled due to the possibility of the products containing unacceptable levels of NDMA.
The FDA and EMA have accepted licence applications for ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS).
European Pharmaceutical Review investigates five of the latest cancer drug approvals and clinical trial results.
An external review of the medicine Beovu has been announced by Novartis, which produces the drug, according to a new report.
The developers of Zejula (niraparib) have announced the FDA will assess the sNDA application under the Real-Time Oncology Review (RTOR) pilot programme.
Once patents expire for biologic medicines, a market opportunity opens up for biosimilars, a cheaper alternative. With more patents due to expire soon, what will the future look like for biologic medicines?
The generic of ProAir HFA (albuterol sulfate) inhalation aerosol has been approved by the FDA to advance patient access to lower-cost medicines.
European Pharmaceutical Review rounds up the latest news surrounding COVID-19, including a vaccine moving to clinical trials and the FDA's update on Chinese import inspections.
The FDA has released a statement that two of its centres will collaborate to provide information on gene-drug interactions they believe have sufficient supporting evidence.
A report released by pharmaceutical industry leaders in the US demonstrates how blockchain helps to track and trace prescription medicines.
