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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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Lilly shares positive Verzenio data as adjuvant early breast cancer therapy

Results were shared in The Lancet Oncology and at the San Antonio Breast Cancer Symposium

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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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Novartis announces positive phase 3 results for prostate cancer drug Pluvicto

The study met its primary endpoint of radiographic progression-free survival

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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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Lilly’s donanemab shows promise in early symptomatic Alzheimer’s comparator study

Brain amyloid clearance was achieved in 37.9% of patients treated with the investigational antibody

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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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Novartis and MMV to advance new malaria drug combination to phase 3 study

The announcement comes as the threat of resistance to current malaria treatments grows

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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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