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- PMLiVE

Alprolix

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FDA approves BMS’s Opdualag for metastatic or unresectable melanoma

The new, first-in-class fixed-dose dual immunotherapy combination treatment is administered as a single intravenous infusion

- PMLiVE

Merck’s Keytruda receives FDA approval for advanced endometrial cancer

The approval was based on new data from the KEYNOTE-158 trial

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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

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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

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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

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Novo Nordisk’s collaboration with MIT and BWH expanded

The new agreement means that the collaboration has been extended until 2026

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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

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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

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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

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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

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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