regulatory approval | pharmaphorum

Wednesday 27 November 2024

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regulatory approval

News

Gamida Cell CEO Abbey Jenkins

FDA clears Gamida’s cord blood therapy for cancer patients

The FDA has approved a stem cell-based therapy for cancer patients from Israeli biotech Gamida Cell that is designed to help them recover more quickly from aggressive chem

News

Ghana first country to approve Oxford malaria vaccine

Ghana first country to approve Oxford malaria vaccine

A malaria vaccine developed by members of the University of Oxford team that created the AstraZeneca COVID-19 jab has been approved in its first market, Ghana.

News

FDA clears Keytruda/Padcev regimen for bladder cancer

FDA clears Keytruda/Padcev regimen for bladder cancer

The combination of Merck & Co’s checkpoint inhibitor Keytruda and Seagen/Astellas’ antibody-drug conjugate Padcev has been approved by the FDA as an alternative to che

News

Pharming brings first drug for rare disease APDS to US

Pharming brings first drug for rare disease APDS to US

Joenja will launch in April and could make upwards of $200m a year in sales, say analysts.

News

candida albicans

Rezzayo antifungal okayed as Candida auris rings alarm bells

Drug is first new echinocandin to be approved for marketing in the US in more than a decade.

News

FDA removes leash from Verzenio in early breast cancer

FDA removes leash from Verzenio in early breast cancer

Drug can now be used as adjuvant therapy without Ki-67 testing, taking a brake off prescribing.