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- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Merck and Orna agree on deal worth $3.5bn for RNA technology

The companies will work together to develop proprietary circular RNA technology

- PMLiVE

AstraZeneca and Merck’s Lynparza combination therapy receives FDA priority review in first-line prostate cancer

Prostate cancer is the second most common cancer in male patients in the US, projected to cause around 35,000 deaths in 2022

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

AstraZeneca and Daiichi Sankyo announce results for lung cancer therapy

Initial results for the combination therapy – with Merck’s Keytruda – show an overall response rate of 37% in patients with non-small cell lung cancer

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