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AAT deficiency

- 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

- PMLiVE

AbbVie’s Rinvoq granted NICE recommendation as ulcerative colitis treatment

The recommendation is for adults living with the condition in England and Wales

- PMLiVE

AbbVie’s Skyrizi receives EC approval for active Crohn’s disease

The approval makes Skyrizi the first specific IL-23 inhibitor as a Crohn's treatment in the EU

- 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

Roche’s high-throughput monkeypox test approved for emergency use by FDA

The tests will be conducted on the company’s 6800/8800 cobas systems

- PMLiVE

FDA advisory committee recommends Ardelyx’s Xphozah for chronic kidney disease

The phase 3 trials supporting the submission met all primary and key secondary endpoints

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