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Marketing Authorisation Application validated for cystic fibrosis treatment
The application was supported by positive results from two global Phase III studies in people with cystic fibrosis aged 12 and older.
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European Medicines Agency (EMA)
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‘Revolutionary’ liquid sickle cell treatment has been unveiled
A new liquid formulation of hydroxycarbamide to treat sickle cell disease will “enable doctors to personalise doses in children".
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Sanofi announces voluntary recall of Zantac products
The pharmaceutical company Sanofi is voluntarily recalling its OTC Zantac products in the US and Canada due possible contamination with NDMA.
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Seven medicines recommended for approval by EMA
The EMA CHMP has given a positive opinion for marketing authorisation approval to seven medicines following its October meeting.
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First non-injectable treatment for severe hypoglycaemia recommended
Marketing authorisation in the EU for Baqsimi, the first non-injectable treatment for very low levels of blood sugar, has been recommended by an EMA committee.
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EMA releases guidance to companies on avoiding nitrosamines in drugs
The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.
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EMA CHMP recommends seven medicines for approval
The EMA has suggested seven treatments to be granted marketing authorisations and also advocated indication extension for eight drugs.
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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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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…
