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soft tissue sarcoma

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BeiGene’s Brukinsa receives EC approval for marginal zone lymphoma

The BTK inhibitor was also granted an additional year of marketing protection

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Gilead’s Vemlidy gets FDA approval for paediatric patients with chronic hepatitis B infection

The application was supported by positive 24-week data from a phase 2 trial

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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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FDA receives Santhera and ReveraGen’s application for Duchenne muscular dystrophy treatment

The submission includes positive data from the pivotal phase 2b and four open-label studies

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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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Janssen’s Tecvayli granted FDA approval for multiple myeloma

A phase 2 study demonstrated an overall response rate of 61.8% in Tecvayli-treated patients

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AstraZeneca’s Imjudo/Imfinzi combination approved by FDA for unresectable liver cancer

Phase 3 trial results demonstrated a 22% reduction in risk of death versus sorafenib

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Novavax’s COVID-19 vaccine candidate approved for emergency use by FDA as a booster

The authorisation is for those unable to receive an FDA-authorised mRNA bivalent booster

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FDA awards over $38m for advancement of rare disease treatments

Grants will support clinical trials, natural history studies and regulatory science tools

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Kite’s CAR-T therapy Yescarta granted EC approval in second-line lymphoma

The decision is based on results from the phase 2 ZUMA-7 study

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Takeda’s dengue vaccine candidate recommended for approval by CHMP

Dengue disease causes around 390 million infections and 500,000 hospitalisations each year

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Novartis bags CHMP recommendation for prostate cancer drug Pluvicto

The recommendation is for use in combination with androgen deprivation therapy

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