regulatory approval | pharmaphorum

Saturday 7 February 2026

regulatory approval

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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.

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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

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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.

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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.

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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.

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Sanofi gets FDA nod for long-acting haemophilia A drug

Once-weekly Altuviiio could be potential $2 billion-plus blockbuster, according to analysts.