regulatory approval

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Sobi gets EU okay for long-acting haemophilia A drug

The European Commission has approved Sobi’s long-acting factor VIII replacement therapy Altuvoct for the treatment of haemophilia A in the EU, with a broad label that spans all ages and any

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FDA clears Roche digital pathology platform for diagnosis

Roche’s move into the digital pathology category has been boosted by FDA approval of a lab instrument and toolkit for use as an aid to clinical diagnosis.

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FDA says yes to MSD’s 21-valent adult pneumococcal jab

The rivalry between Pfizer and MSD in pneumococcal vaccines has dialled up a notch with the FDA approval of MSD’s new shot Capvaxive, the first to be aimed specifically at adults.

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FDA widens label for BMS’ cancer drug Augtyro

Bristol-Myers Squibb has claimed FDA approval for a new, tumour-agnostic indication for Augtyro, the cancer drug it acquired as part of its $4.1 billion takeover of Turning Point Therapeuti

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FDA clears Ipsen’s primary biliary cholangitis drug

Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the first dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (

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Close-up view of an actinic keratosis lesion

FDA OKs wider use of Almirall’s actinic keratosis drug

With actinic keratosis (AK) diagnoses on the rise, there is some good news for patients, with the FDA approval of expanded use of Almirall’s topical therapy Klisyri.

Sobi gets EU okay for long-acting haemophilia A drug

FDA clears Roche digital pathology platform for diagnosis

FDA says yes to MSD’s 21-valent adult pneumococcal jab

FDA widens label for BMS’ cancer drug Augtyro

FDA clears Ipsen’s primary biliary cholangitis drug

FDA OKs wider use of Almirall’s actinic keratosis drug

CDC panel votes to scrap hepatitis B birth dose advice

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regulatory approval

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