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- PMLiVE

priority review

- PMLiVE

GSK’s new global survey exposes lupus treatment gaps

The findings show opportunities to address organ damage risk for early stage lupus patients

- PMLiVE

FDA approves first drug to delay onset of type 1 diabetes

Provention Bio’s Tzield delayed the average onset of type 1 diabetes by over four years

- PMLiVE

Sanofi/GSK’s next-generation COVID-19 booster granted EC approval

Two trials compared the immune response induced by VidPrevtyn Beta with approved vaccines

- PMLiVE

FDA approves Seagen’s Adcetris combination for paediatric patients with Hodgkin lymphoma

Patients had a 59% reduction in the risk of disease progression or relapse, second cancer or death

- PMLiVE

Sobi’s Kineret granted FDA Emergency Use Authorisation for COVID-19 related pneumonia

The IL-Ra1 inhibitor was found to reduce the risk of disease progression by 64%

- PMLiVE

GSK to submit drug application for new antibiotic to US FDA

Gepotidacin could be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years

- PMLiVE

AstraZeneca/Sanofi’s Beyfortus receives EC approval for prevention of RSV in infants

The decision makes the antibody the first broadly protective option for this age population

- PMLiVE

Pfizer’s maternal RSV vaccine candidate shows promise in phase 3 trial

The company stopped the trial early and plans to file for US approval by the end of 2022

- PMLiVE

GSK’s respiratory syncytial virus older adult vaccine given Priority Review by FDA

There are currently no RSV vaccines approved for older adults anywhere worldwide

- PMLiVE

GSK’s application for its RSV vaccine accepted by EMA under accelerated assessment

The vaccine demonstrated overall efficacy of 82.5% in adults aged 60 years and older

- PMLiVE

GSK’s ViiV submits application for cabotegravir to EMA for HIV-1 prevention

Cabotegravir offers up to two months of protection from a single injection

- PMLiVE

GSK’s anaemia drug gets FDA advisory committee support for patients on dialysis

A final decision for daprodustat by the FDA is expected by 1 February 2023

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