FDA
Already approved for erosive gastroesophageal reflux disease, Phathom’s Voquenza is now authorized to treat patients with non-erosive GERD.
Agenus is now looking for alternative pathways to initiate a Phase III trial for BOT/BAL, including potential partnerships.
Citing the need for another human factor study and more technical data for the final product, the FDA denied approval of Orexo’s nasal spray rescue medication for opioid overdose.
To improve its reviewers’ understanding of cell and gene therapy manufacturing, the agency has launched a program that will involve a tour of manufacturing facilities and daily workshops for its staffers.
Why I advocated on Capitol Hill this month for the renewal of the FDA’s Priority Review Voucher program
The FDA’s Complete Response Letter turned down Novo Nordisk’s Biologics License Application for its once-weekly basal insulin icodec injection for diabetes mellitus, with “requests” related to the manufacturing process and the type 1 diabetes indication.
The regulator Tuesday added atopic dermatitis to the label of Arcutis Biotherapeutics’ topical PDE4 inhibitor Zoryve for the treatment of patients six years of age and older.
Roche’s eye implant Susvimo for patients with neovascular age-related macular degeneration is re-entering the U.S. market after the FDA approved updates to the components of the product.
The groundwork being done in 2024 is building the foundation for global collaboration in the future.
Two CRLs from the FDA last week cited concerns with third-party manufacturers, while Indian CDMOs may make a bid for U.S. business if there is a decoupling from Chinese companies under the BIOSECURE Act.
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