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- PMLiVE

GSK immunotherapy

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GSK’s Jemperli shows promise in phase 3 endometrial cancer trial

An interim analysis noted the trial met its primary endpoint of progression-free survival

- PMLiVE

FDA approves Scynexis’ Brexafemme for recurrent vulvovaginal candidiasis

The antifungal is already approved in the US for vulvovaginal candidiasis

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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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GSK’s new global survey exposes lupus treatment gaps

The findings show opportunities to address organ damage risk for early stage lupus patients

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Precision medicine trial opens for patients with rare cancers

Rare cancers make up 22% of cancers that are diagnosed globally each year, more than any single type of cancer

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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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FDA approves first drug to delay onset of type 1 diabetes

Provention Bio’s Tzield delayed the average onset of type 1 diabetes by over four years

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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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Roche enters into second collaboration with Jnana to address complex drug targets

The Boston-based biotech will receive an upfront payment of $50m

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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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Sanofi/GSK’s next-generation COVID-19 booster granted EC approval

Two trials compared the immune response induced by VidPrevtyn Beta with approved vaccines

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