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- PMLiVE

FDA to review requirements for future booster shots for COVID-19

The meeting will be streamed live on the FDA’s YouTube channel and a webcast will be provided on the FDA website

- PMLiVE

Moderna applies to FDA for authorisation for second COVID-19 booster shot for all adults

The second booster shot would be for adults 18 years and over who have already had one authorised COVID-19 booster shot

- PMLiVE

Sanofi reveals $330m collaboration with Blackstone Life Sciences

The partnership will focus on innovative treatment for multiple myeloma

- PMLiVE

Sanofi experiences setback in phase 2 breast cancer trial

The AMEERA-3 trial tested women aged 18 and over with hormone receptor-positive, HER2-negative advanced breast cancer

- PMLiVE

Pfizer highlights need for fourth dose of COVID-19 vaccine to FDA

While new study published in The Lancet shows COVID-19 mortality rate is almost three times higher than previously thought

- PMLiVE

FDA approves BMS’ Opdivo with chemotherapy for certain lung cancer patients

This is the first and only immunotherapy-based treatment approved for use before surgery for patients with non-small cell lung cancer

- PMLiVE

bluebird bio shares therapy updates for 2022

The company provided information for its first two gene therapies and its lovo-cel BLA submission for sickle cell disease

- PMLiVE

FDA issues final guidances for clinical cancer trials

The FDA is working to address inequities, target the right treatments to the right patients and speed progress against the most deadly and rare cancers

- PMLiVE

Janssen and Legend Biotech’s Carvykti receives FDA approval for patients with relapsed or refractory multiple myeloma

In the study, 98% of patients with relapsed or refractory multiple myeloma responded to a one-off treatment of the drug

- PMLiVE

Sanofi and Regeneron announce positive phase 3 trial results for Dupixent

The trial involved patients with eosinophilic oesophagitis, an inflammatory disease that damages the oesophagus and makes eating and drinking painful

Biomarin

FDA keeps BioMarin’s gene therapy for phenylketonuria on hold

The decision follows data suggesting BioMarin’s experimental gene therapies may have the potential to progress cancers

- PMLiVE

Eli Lilly’s Omicron drug treatment gets emergency use authorisation from FDA

The drug can be used to treat adults with mild-to-moderate COVID-19, and children aged 12 or older, in specific emergency cases in non-hospital settings

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