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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

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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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FDA approves Scynexis’ Brexafemme for recurrent vulvovaginal candidiasis

The antifungal is already approved in the US for vulvovaginal candidiasis

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AZ and MSD launch ‘Never Miss’ for prostate cancer awareness

Prostate cancer is often symptomless and is the second most common cancer in men globally

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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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AstraZeneca to acquire Neogene Therapeutics in $320m deal

The agreement will build the company’s pipeline of cell-based cancer treatments

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AstraZeneca and C4X Discovery sign exclusive $403m licensing deal

The collaboration aims to develop an oral therapy for inflammatory and respiratory diseases

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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

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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

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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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FDA approves ImmunoGen’s Elahere for platinum-resistant ovarian cancer

An overall response rate of 31.7% was demonstrated, including five complete responses

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AstraZeneca receives CHMP recommendations for Imfinzi, Enhertu and Lynparza

The treatments are for use in prostate, biliary tract and advanced gastric cancer

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