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Wellcome

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GSK to submit drug application for new antibiotic to US FDA

Gepotidacin could be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years

- PMLiVE

GSK’s respiratory syncytial virus older adult vaccine given Priority Review by FDA

There are currently no RSV vaccines approved for older adults anywhere worldwide

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GSK’s application for its RSV vaccine accepted by EMA under accelerated assessment

The vaccine demonstrated overall efficacy of 82.5% in adults aged 60 years and older

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GSK’s ViiV submits application for cabotegravir to EMA for HIV-1 prevention

Cabotegravir offers up to two months of protection from a single injection

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GSK’s anaemia drug gets FDA advisory committee support for patients on dialysis

A final decision for daprodustat by the FDA is expected by 1 February 2023

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GSK’s shingles vaccine demonstrates at least ten-year efficacy in long-term study

ZOSTER-049 follows participants from two phase 3 trials for an additional six years

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Merck and Bill & Melinda Gates Institute sign licensing agreement for tuberculosis candidates

The non-profit will determine their potential for inclusion in new affordable treatment regimens

- PMLiVE

GSK announces positive phase 3 results of RSV vaccine candidate in older adults

RSV infections in older adults account for around 177,000 hospitalisations in the US each year

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GSK’s Boostrix approved by FDA for use during pregnancy to prevent whooping cough in infants

4.2% of the cases of pertussis reported in the US in 2021 were in infants younger than six months

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MHRA and NICE awarded £1.8m to explore regulation of digital mental health tools

The funding will go towards improving regulatory certainty and safety for mental health products

- PMLiVE

GSK awarded first-ever UNICEF contract for malaria vaccine in deal worth £170m

In 2020, nearly half a million children died from malaria in Africa alone, a rate of one child death per minute

- PMLiVE

CureVac announces start of phase 1 trial of modified COVID-19 mRNA vaccine candidate

Developed in collaboration with GSK, CV0501 is specifically designed to protect against the Omicron variant

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