FDA
AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.
The South Korean company’s Epysqli is now FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome in the U.S., having grabbed the lead in the Soliris biosimilar market in Europe.
After a long and challenging journey for its stem cell therapy NurOwn, BrainStorm Cell Therapeutics has aligned with the FDA on the parameters of a Phase IIIb ALS trial that is expected to begin by the end of 2024.
While type 2 diabetes and obesity are the primary conditions currently treated with blockbuster GLP-1 drugs, Novo Nordisk and Eli Lilly aim to enter additional markets.
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.
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