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- PMLiVE

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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

- PMLiVE

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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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

- PMLiVE

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

- 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

- PMLiVE

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

- PMLiVE

Amylyx’s Relyvrio receives FDA approval for ALS treatment

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

- PMLiVE

Sanofi and Regeneron’s Dupixent approved by FDA for prurigo nodularis

The two phase 3 trials showed a meaningful reduction in itching

- PMLiVE

AstraZeneca’s Tezspire receives MHRA approval as add-on treatment for severe asthma

Tezspire demonstrated reduced annualised rate of asthma exacerbations

- PMLiVE

Pfizer and BioNTech seek FDA authorisation for COVID-19 booster for children

An application will also be submitted to the European Medicines Agency to extend the marketing authorisation for this age group

- PMLiVE

Lilly’s Retevmo approved by FDA for RET fusion+ advanced/metastatic solid tumours

Results demonstrated an overall response rate of 44% across multiple tumour types

- PMLiVE

AstraZeneca’s Tezspire receives EC approval as severe asthma add-on treatment

Tezspire demonstrated superiority across every primary and key secondary endpoint compared to placebo

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