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FDA approves Jardiance® for heart failure with reduced ejection fraction
The FDA have approved Lilly’s Jardiance (empagliflozin) to treat adults living with heart failure with reduced ejection fraction.
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FDA approve GSK’s Jemperli for patients with dMMR solid tumours
GSK receives FDA accelerated approval for Jemperli for adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.
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MHRA approves COVID-19 Vaccine Moderna in 12-17-year olds
The MHRA has approved the use of the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) in children aged 12-17 years old.
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Pfizer and BioNTech submit Phase I data to FDA for COVID-19 booster
Pfizer and BioNTech have announced the submission of initial data to the US FDA to support booster dose of COVID-19 vaccine.
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Moderna announces first patient dosed in mRNA-3705 study
Moderna have announced that the first patient has been dosed in Phase I/II study of mRNA-3705 for methylmalonic acidemia (MMA).
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FDA approves TicoVac™ tick-borne encephalitis (TBE) vaccine
The FDA has approved Ticovac, a tick-borne encephalitis (TBE) vaccine, for people aged one year and older when travelling to TBE endemic areas.
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FDA approve a new indication for Xywav to treat chronic sleep disorder
The FDA have granted a first of its kind indication for Xywav for the treatment of idiopathic hypersomnia (IH) in adults.
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Lebrikizumab displays 75 percent skin clearance in dermatitis patients
Lebrikizumab achieved at least 75 percent skin clearance in more than half of patients with atopic dermatitis (AD), shows Phase III study.
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New NICE draft guidance recommends abemaciclib for breast cancer
NICE has published draft guidance recommending Eli Lilly's twice-daily pill abemaciclib for advanced HER2-negative breast cancer.
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FDA allows additional COVID-19 vaccine dose for immunocompromised
The FDA has authorised an additional dose of COVID-19 Vaccines Pfizer-BioNTech and Moderna in certain immunocompromised patients.
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MHRA approves Epidyolex® (cannabidiol) for TSC seizure treatment
GW Pharmaceuticals received approval for Epidyolex®(cannabidiol) for the treatment of seizures linked to tuberous sclerosis complex (TSC) in the UK.
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Third COVID-19 vaccine dose could improve protection in transplant recipients
The results from the first COVID-19 vaccine booster trial in transplant recipients show a third dose is safe and highly immunogenic.
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Monoclonal antibody prevents malaria in small NIH trial
One dose of a monoclonal antibody developed at the US National Institutes of Health (NIH) prevented malaria for up to nine months.
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Enhertu improves survival in Phase III breast cancer trial
Enhertu (trastuzumab deruxtecan) significantly improved survival in the DESTINY-Breast03 Phase III head-to-head trial against trastuzumab emtansine.
