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Priority review sets up Feb verdict on Sanofi, Sobi haemophi...

The FDA will carry out a speedy review of Sanofi and Sobi's once-weekly haemophilia A treatment efanesoctocog alfa (Bivv001), with a decision now

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FDA clears bivalent Omicron shots from Pfizer, Moderna

As expected, the FDA has moved quickly to grant emergency use authorisation (EUA) to two new-generation COVID-19 mRNA vaccines from Pfizer/BioNTech and Moderna, both targeting the new Omicr

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Roctavian okay sets up another gene therapy test for Europe

BioMarin Pharma has its landmark first approval for Roctavian – the first for a haemophilia gene therapy – and will now have to see if that can convert that into a viable business in Europe

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Janssen J&J Johnson and Johnson pharmaceutical companies

J&J gets first approval for multiple myeloma bispecific Tecv...

Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with

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Dengue, zika and chikungunya fever mosquito (aedes aegypti) on human skin

Takeda gets first approval for its dengue vaccine

Japan's Takeda has secured its first regulatory approval – in Indonesia – for its dengue fever vaccine TAK-003, which has been tipped as a potential blockbuster product.

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Are rapid progress and patient engagement mutually exclusive in a COVID-19 world?

Pfizer, BioNTech seek US okay for Omicron BA.4/BA.5 booster

Pfizer and BioNTech have asked the FDA for emergency authorisation of an Omicron-targeted COVID-19 booster vaccine ahead of the planned autumn immunisation campaign in the US.

Priority review sets up Feb verdict on Sanofi, Sobi haemophi...

FDA clears bivalent Omicron shots from Pfizer, Moderna

Roctavian okay sets up another gene therapy test for Europe

J&J gets first approval for multiple myeloma bispecific Tecv...

Takeda gets first approval for its dengue vaccine

Pfizer, BioNTech seek US okay for Omicron BA.4/BA.5 booster

Sanofi drops two more programmes in R&D clear-out

Discover a new era of healthcare panel engagement: Grounded ...

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