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- 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

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

Sanofi halts recruitment for trials assessing MS treatment

The pause in enrolment follows advice issued by the Independent Data Monitoring Committee

- PMLiVE

FDA approves Bot Image’s AI software for the detection and diagnosis of prostate cancer

ProstateID combines artificial intelligence with traditional MRI scanning to significantly improve radiologic interpretation accuracy

- PMLiVE

AstraZeneca and Daiichi Sankyo get FDA approval for breast cancer drug

Results from a phase 3 trial showed Enhertu reduced the risk of disease progression or death by 50%

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Bayer’s Nubeqa receives FDA approval to treat metastatic prostate cancer

The risk of death was reduced by 32% by adding the drug to standard therapy

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