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Pemigatinib

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Incyte’s JAK inhibitor cream Opzelura shows promise in hidradenitis suppurativa

The treatment already holds approvals in non-segmental vitiligo and atopic dermatitis

- PMLiVE

Incyte shares positive results for Opzelura cream in children with atopic dermatitis

Two to three million children aged two to 11 years in the US are affected by atopic dermatitis

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Incyte’s Opzelura cream receives EC approval for non-segmental vitiligo

The decision makes Opzelura the first approved treatment in the EU to address repigmentation in this patient population

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Incyte and Biotheryx collaborate to develop protein degraders for oncology targets

Biotheryx will receive up to $347m in potential milestone payments

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bluebird bio sells second FDA priority review voucher for $95m

The company sold its first voucher to Dutch biotech Argenx for $102m

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FDA approves Ferring’s Adstiladrin as first gene therapy for bladder cancer

Non-muscle-invasive bladder cancer represents around 75% of all new bladder cancer cases

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Roche’s COVID-19 antibody receives FDA approval for hospitalised adults

The decision makes Actemra the first FDA-approved monoclonal antibody to treat COVID-19

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FDA lifts partial clinical hold on bluebird bio’s sickle cell gene therapy studies

The company can now resume the enrolment and treatment of patients aged two to 17 years

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FDA approves updated COVID-19 boosters for children aged from six months

The Moderna and Pfizer/BioNTech boosters both target the BA.4/BA.5 omicron subvariants

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Pfizer’s RSV vaccine candidate accepted for FDA priority review for use in older adults

A phase 3 study showed the vaccine was 85.7% effective in those with three or more symptoms

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Pfizer/BioNTech submit FDA application for BA.4/BA.5 COVID-19 vaccine in children under five

The vaccine is already authorised as a booster for ages five years and older in the US and EU

- PMLiVE

FDA approves Rigel’s Rezlidhia for acute myeloid leukaemia

Phase 2 data showed a complete remission rate of 35% and median duration of 25.9 months

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