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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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Novartis bags CHMP recommendation for prostate cancer drug Pluvicto

The recommendation is for use in combination with androgen deprivation therapy

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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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WHO unveils AI-powered digital health worker, Florence 2.0

The chatbot builds on its previous version, which was used to tackle COVID-19 misinformation

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Brainomix set to collaborate with NCIMI to assess AI-powered tech in lung cancer care

The partnership will compare automated evaluation versus observations of medical specialists

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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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Pfizer’s Talzenna combination treatment meets primary endpoint in phase 3 prostate cancer study

An improvement in radiographic progression-free survival was demonstrated

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InflaRx seeks FDA authorisation for vilobelimab for critically ill COVID-19 patients

A phase 3 study showed that the antibody reduced the all-cause mortality rate after 28 days

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Amylyx’s Relyvrio receives FDA approval for ALS treatment

Relyvrio was shown to significantly slow physical decline in people living with ALS

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