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- PMLiVE

Stephen Hahn

- PMLiVE

Pfizer/BioNTech announce positive early data from trial of BA.4/BA.5 COVID-19 booster

A 30µg dose of the booster demonstrated a ‘substantial increase’ in antibody response

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

- 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

- 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

regeneron headquarters

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

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

Shionogi signs licence agreement with MPP for COVID-19 oral antiviral treatment

The agreement aims to increase access to ensitrelvir in low- and middle-income countries

- 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

Shionogi’s antiviral COVID-19 treatment meets phase 3 primary endpoint

Ensitrelvir reduced the time taken to resolve five key symptoms

- PMLiVE

WHO reports warnings of ‘COVID-19 complacency’ from countries tracking global vaccine roll-out

Vaccination rates in low-income countries stand at 19% compared to almost 75% in high-income countries

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