Keeping Track: US FDA Clears Vtama, But Not Bimekizumab Or Ycanth; Tibsovo Takes RTOR To Frontline AML Setting
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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As the COVID-19 pandemic wore on, industry clamored for the US FDA to re-inspect troubled drug manufacturing plants remotely if need be to clear them for new approvals. Now FDA investigators are out in force and early returns from Sun, Aurobindo, Lupin and Sterling suggest these re-inspections will be as tough as ever.
The firm is planning a US NDA filing after its roflumilast formulation succeeded in a pivotal seborrheic dermatitis study but analysts are keener on a ‘make or break’ approval in psoriasis.
The UK Health Security Agency says it took a number of factors into account when deciding to use Bavarian Nordic’s smallpox vaccine Imvanex, including high European manufacturing standards, the US approval for monkeypox, and the lack of an alternative UK-licensed vaccine.