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- PMLiVE

pre-exposure prophylaxis (PrEP)

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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

Biomarin

BioMarin’s application for haemophilia A gene therapy accepted by FDA

If approved, the treatment would be the first gene therapy in the US for this indication

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Pfizer/BioNTech BA.4/BA.5 COVID-19 booster approved for emergency use by FDA in children five to 11 years

The doses will be shipped immediately, pending recommendation from the CDC

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Genentech shares positive two-year data for Evrysdi in spinal muscular atrophy study

The study enrolled the ‘broadest and most diverse’ patient population ever studied in an SMA trial

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