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- PMLiVE

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

- PMLiVE

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

- PMLiVE

Pfizer and Clear Creek Bio partner on COVID-19 antiviral research programme

The companies will identify a papain-like protease candidate to progress into the clinic

- PMLiVE

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

- PMLiVE

Pfizer and Roivant form new company to develop inflammatory disease drug

RVT-3101 is currently being evaluated in a global phase 2b study for ulcerative colitis

- PMLiVE

Pfizer and Valneva report six-month antibody persistence data for Lyme disease vaccine

VLA15 is the only Lyme disease vaccine candidate currently in clinical development

- PMLiVE

FDA approves Scynexis’ Brexafemme for recurrent vulvovaginal candidiasis

The antifungal is already approved in the US for vulvovaginal candidiasis

- PMLiVE

bluebird bio sells Rare Pediatric Disease Priority Review Voucher

The company was granted two PRVs upon the FDA approvals of Zynteglo and Skysona

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MHRA approves LEO Pharma’s Adtralza for adolescent patients with atopic dermatitis

The changes to the terms were also approved by the EC in October

- PMLiVE

FDA approves first gene therapy for adults with haemophilia B

CSL’s Hemgenix allowed patients to produce mean factor IX activity of 39% at six months

- PMLiVE

Sanofi’s Enjaymo receives EC approval for rare autoimmune haemolytic anaemia

Cold agglutinin disease affects around 12,000 people in the US, Europe and Japan

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