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

The two phase 3 trials showed a meaningful reduction in itching

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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

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Roche announces launch of HPV self-sampling solution for cervical cancer screening

Around 342,000 die from cervical cancer worldwide, despite it being a preventable disease

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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

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

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

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Roche’s Vabysmo receives EC approval to treat two leading causes of vision loss

60% of people treated with Vabysmo were able to extend treatment to every four months

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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

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Regeneron’s fianlimab/Libtayo combination shows positive results in advanced melanoma treatment

The results were shared at the European Society for Medical Oncology Congress 2022

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Regeneron’s Libtayo shows promising results in phase 2 skin cancer trial

In the phase 2 trial, 50.6% of patients achieved the primary endpoint of complete pathologic response

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