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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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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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Moderna seeks FDA Emergency Use Authorisation for BA.4/BA.5 COVID-19 booster

The application is 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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Merck granted fast track designation by FDA for end-stage renal disease therapy

MK-2060 is currently being investigated in a phase 2 study to evaluate the efficacy and safety of two different doses

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Pfizer and BioNTech seek FDA Emergency Use Authorisation for BA.4/BA.5 COVID-19 booster

The companies have rapidly increased production of the newly developed vaccine and are ready to deliver doses from September

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Pfizer told by FDA to test additional Paxlovid course in patients with COVID-19 rebound

The company must produce the initial results of a randomised controlled trial by 30 September next year

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GSK’s application for momelotinib in myelofibrosis with anaemia accepted by FDA

40% of myelofibrosis patients are already anaemic at the time of diagnosis and nearly all patients are estimated to develop anaemia eventually

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