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- PMLiVE

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

- 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

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

AbbVie shares positive phase 3 results for migraine drug Qulipta

The impact of chronic migraines on patients can be debilitating

- 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

AbbVie acquires Syndesi Therapeutics in $1bn deal

The deal will allow AbbVie to access Syndesi’s research into Alzheimer's disease

- 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

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

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