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FDA accepts Biologics License Application for V920 Ebola vaccine
A Biologics License Application and priority review has been approved by the FDA for an investigational Ebola vaccine.
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European Medicines Agency (EMA)
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EMA to provide guidance on avoiding nitrosamines in medicines
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
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NDMA discovered in samples of ranitidine medicines
The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
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Showcasing a monthly injectable HIV treatment
Janssen’s Brian Woodfall discusses the pharmaceutical company’s research process for their monthly injectable HIV treatment and their predictions for the future of the condition.
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Real-world data and its endless potential
The possibilities presented by real-world data to improve drug development processes could enhance regulatory and pricing decisions for new therapeutics.
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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.
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EMA to review Picato after rise in skin cancer cases
The EMA will assess the marketing authorisation for the medication to see whether it is a cause of skin cancer in patients.
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China and the evolving regulatory landscape
The Chinese pharmaceutical industry has been lagging behind in terms of drug development and bringing new products to the market. In this article, Megha Baruah discusses the changes the National Medical Products Administration (NMPA) of China is making to existing policies and informs on guidance documents that have been released…
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Allowable levels of excipients in drug products
Medicinal products typically cannot be manufactured without using excipients. Here, Dave Elder and Fabio Faïs discuss factors for excipient selection and the importance of defined allowable limits to ensure continued product safety.
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Licence extension submission accepted for kidney disease treatment by EMA
The licence extension submission for Invokana and Vokanamet has been accepted by the EMA.
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FDA and EMA align on 90 percent of marketing authorisation decisions
A study has found that between 2014 and 2016, the EMA and FDA had very little divergence in their marketing authorisation decisions.
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RINVOQ™ arthritis treatment granted approval by FDA
The FDA has given its approval to RINVOQ for the treatment of active rheumatoid arthritis after the drug reached its endpoints in clinical trials.
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Imbruvica® granted expanded use from European Commission
The European Commission has approved the drug for two indications: chronic lymphocytic leukaemia and Waldenström's macroglobulinemia.
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Liposomal medicine names to be changed to avoid errors
The EMA has requested that liposomal medication names be changed to avoid the risk of confusion.
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Cannabidiol-based treatment receives marketing approval from EMA
EMA’s human medicines committee had cleared the cannabidiol oral solution, Epidiolex, for use to treat seizures.
