A Regeneron Pharmaceuticals drug that lowers levels of a disease-driving protein has met the goals of a pivotal test in the rare disease generalized myasthenia gravis. Based on these results, ...
Q1 2026 Management View "This continues to be an active and important period for our business as we execute on the opportunities ahead and remain focused on positioning the company for its next phase ...
Trelegy Ellipta is a maintenance treatment for patients with asthma and COPD. "The FDA's acceptance of our ANDA filing for ...
FDA filing covers renewal applications for VLN® King and VLN® Menthol King, the first combusted cigarettes authorized as Modified Risk Tobacco Products, as 22nd Century advances its regulatory pathway ...
The US Food and Drug Administration (FDA) published the internal checklists its staff reference when reviewing drug and biologics applications to determine whether the submission is complete, or ...
When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when ...
The Food and Drug Administration (FDA) has issued a Refuse-to-File (RTF) letter to Moderna, Inc. regarding its Biologics License Application (BLA) for the investigational mRNA-based influenza vaccine ...
BioCardia said it "expect [s]" the Japan Shonin application "will take approximately 7 months to prepare and submit" (CEO, President & Director Altman) and described a post-submission "about a ...
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