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CHMP meeting highlights – January 2025
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
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thrombocytopenia
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Optimising iPS cell-based platelet manufacturing scale up
Large-scale platelet manufacturing must consider turbulent energy and shear stress as well as the undesired turbulent flow space within a bioreactor, the paper concluded.
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Vaxzevria has similar safety profile to mRNA COVID-19 vaccines, finds study
New studies show rates of blood clots were similar following vaccination with Vaxzevria and Comirnaty®, plus rates of rare blood clots are lower after the second Vaxzevria dose.
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Highlights of the May 2021 Pharmacovigilance Risk Assessment Committee (PRAC) meeting
In its May meeting, the EMA’s drug safety committee (PRAC) concluded two safety signal reviews for COVID-19 vaccines and began several more.
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Cytokine storms: a major killer in patients with severe COVID-19 infection
Professor Saad Shakir explains why cytokine storms occur in COVID-19 patients and suggests potential therapies for the symptoms of the coronavirus.
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Summarising 2019: a year of firsts for the EMA
The EMA was a proactive force in 2019, granting marketing authorisation for a range of drugs. This article highlights some of the most important advancements made by the agency last year.
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FDA grants Avatrombopag Orphan Drug Designation for thrombocytopenia
The US FDA has granted avatrombopag (Doptelet) ODD as around 10 percent of US cancer patients per year experience chemotherapy-induced thrombocytopenia (CIT) with no available treatment.
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FDA approves Doptelet for thrombocytopenia in chronic liver disease
The FDA has approved Doptelet tablets to treat low blood platelet count in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure...
