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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

- PMLiVE

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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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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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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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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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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Regeneron’s application for Eylea in retinopathy of prematurity accepted for FDA priority review

The rare eye disease often impacts infants who are born before 31 weeks of pregnancy

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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

- PMLiVE

Eli Lilly granted fast track designation by FDA for obesity treatment

The company plans to initiate a rolling submission of a new drug application for tirzepatide this year

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