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- PMLiVE

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

- PMLiVE

AstraZeneca’s Farxiga data shows ‘significant’ mortality benefits in heart failure patients

The pre-specified pooled analysis from two phase 3 trials demonstrated a reduction in cardiovascular death by 14%

- PMLiVE

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

- 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

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

AstraZeneca and Daiichi Sankyo’s Enhertu shows significant improvement for breast cancer patients

The phase 3 trial compared Enhertu against a treatment pre-determined by physicians in people with HER2-positive metastatic breast cancer

- 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

Lack of evidence for AstraZeneca’s COVID-19 vaccine says UK Department of Health

Charities have called on the government to reassess its decision, which could affect the immunocompromised

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