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MNK-795

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Enhertu to provide patients with vital targeted therapy option

Therapy receives FDA priority review as patients with HER2-mutant metastatic non-small cell lung cancer seek alternative treatment

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FDA delays Merck’s pneumococcal vaccine Vaxneuvance

It is predicted that the vaccine could make over $1bn in peak sales

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FDA grants Pfizer/BioNTech expanded EUA for an additional COVID-19 vaccine booster

The second booster authorisation is for those aged 50 years and older to promote high levels of protection against COVID-19 in the most vulnerable groups

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FDA approves Novartis’ Pluvicto for prostate cancer

The treatment is the first FDA approved targeted radioligand therapy for mCRPC patients

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Pfizer receives Breakthrough Therapy Designation from FDA for RSV vaccine candidate

There are currently no preventative, therapeutic or vaccine options for older adults diagnosed with RSV

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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

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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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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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