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cardiovascular drug

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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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Dexcom launches next-generation continuous glucose monitor for diabetes patients

The monitor allows patients to track their glucose levels without using a finger prick test

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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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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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Novo Nordisk’s insulin icodec shows promise as once-weekly type 2 diabetes treatment

Currently, the basal insulin products with the longest duration are injected once daily

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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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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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Moderna granted FDA authorisation for emergency use of BA.4/BA.5-targeting bivalent COVID-19 booster

The application was based on preclinical data and clinical trial data available from a phase 2/3 study evaluation of the company's BA.1 Omicron-targeting bivalent booster candidate

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Sanofi and Sobi’s efanesoctocog alfa granted FDA priority review for haemophilia A

Phase 3 results showed once-weekly doses provided clinically meaningful bleed protection for patients with haemophilia A

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