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Six COVID-19 boosters are safe and effective, shows Phase II study
Study finds six different COVID-19 vaccine boosters increase immunity and pose no safety concerns, although immune responses varied.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Dec 2021
EMA's drug safety committee (PRAC) confirmed the risks of myocarditis and pericarditis with COVID-19 messenger RNA (mRNA) vaccines.
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CHMP issue positive opinion on Comirnaty® for five to 11 year olds
The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.
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NICE recommends osimertinib for non-small cell lung cancer (NSCLC)
Over 600 people may benefit as NICE publishes final draft guidance recommending osimertinib within the Cancer Drugs Fund.
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FDA approves new imaging drug to identify ovarian cancer lesions
The US Food and Drug Administration (FDA) approves Cytalux to help identify cancerous lesions during ovarian cancer surgery.
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EC approve Zeposia® to treat ulcerative colitis
The European Commission (EC) has granted Zeposia® (ozanimod) a marketing authorisation to treat people with ulcerative colitis.
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AZD7442 reduces COVID-19 risks by 83 percent in Phase III trial
A separate treatment trial showed 88 percent reduced risk of severe COVID-19 or death when treated within three days of symptom onset.
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EMA issues advice on use of Lagevrio for the treatment of COVID-19
The Europe Medicines Agency (EMA)'s human medicine committee advise (CHMP) that Lagevrio can be used for COVID-19 patients who do not require oxygen and are at increased risk.
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FDA approves first drug to treat common form of dwarfism in children
The US Food and Drug Administration (FDA) approves vosoritide injection to improve growth in children at least five years of age with achondroplasia and open epiphyses.
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Oral milvexian reduces risk of postoperative venous thromboembolism
Milvexian showed a 12 percent rate of postoperative venous thromboembolism compared to the benchmark rate of 30 percent in a Phase II study.
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Crohn’s patients achieve 65 percent clinical remission with Tremfya®
At week 48 of the Phase II trial, 65 percent of patients with Crohn's disease receiving Tremfya® achieved clinical remission.
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European Commission grants marketing authorisation for Vumerity®
The European Commission (EC) has granted marketing authorisation for Vumerity® to treat adults with relapsing-remitting multiple sclerosis.
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FDA approves Besremi to treat rare blood disease
The US Food and Drug Administration (FDA) approves Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera.
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Drug combination an alternative leukaemia treatment to chemotherapy
A clinical trial found that all-trans retinoic acid and arsenic trioxide is an effective treatment for acute promyelocytic leukaemia.
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EMA endorses two monoclonal antibody medicines for COVID-19
The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Ronapreve™ and Regkirona for COVID-19.
