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- 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

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

Pfizer and Sangamo Therapeutics reopen recruitment for haemophilia A gene therapy trial

The trial was voluntarily paused by the two partners last year and later placed on hold by the FDA

- PMLiVE

Pfizer to supply 6 million Paxlovid treatments to low- and middle-income countries

Eligible countries will be offered treatment courses according to Pfizer’s tiered pricing approach

- 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

bluebird bio’s Skysona approved by FDA to treat cerebral adrenoleukodystrophy

The gene therapy was shown to slow the progression of neurologic dysfunction

- PMLiVE

AstraZeneca/Sanofi’s Beyfortus receives CHMP recommendation for prevention of RSV disease in infants

Beyfortus reduced the incidence of medically attended lower respiratory tract infections caused by RSV

- PMLiVE

Pfizer’s investigational meningococcal vaccine shows promise in phase 3 trial

There is currently no single vaccine available in the US to help protect against the main five serogroups

- PMLiVE

FDA and NIHR launch public-private partnership for rare neurodegenerative diseases

The announcement follows President Biden signing the Accelerating Access to Critical Therapies for ALS Act in December 2021

- PMLiVE

Pfizer doses first patients with mRNA-based influenza vaccine

Available vaccine strains that match circulating influenza viruses offer only 40%-60% protection

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