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Ironwood Pharmaceuticals

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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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Novartis reports death of two patients treated with Zolgensma

The company has notified health authorities in markets where the drug is sold and has informed relevant healthcare professionals

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New research shows drug candidate may effectively treat antibiotic-resistant bacteria

Research published in The American Chemical Society Central Science journal has shown that Fabimycin may be effective against more than 200 antibiotic-resistant bacteria

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AstraZeneca and Daiichi Sankyo receive FDA approval for lung cancer drug

A phase 2 trial demonstrated an overall response rate of 57.7% in patients with non-small cell lung cancer

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Roche’s Xofluza issued FDA approval to treat influenza in children aged five years and older

It is the first and only single-dose oral medicine for this indication in children as young as five

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