Pictured: A scientist works behind an FDA sign/Taylor Tieden for BioSpace
The FDA approved 55 new drugs and 34 cell and gene therapies in 2023. But it’s not always good news that companies have to deliver to their stakeholders; the year also had its fair share of Complete Response Letters.
As we embark on 2024, BioSpace is committed to keeping you up-to-date on all the FDA’s actions in this FDA Decision Tracker.
April
April 2
Product: Vanda Pharmaceuticals’ Fanapt
Indication: Bipolar I disorder
Vanda Pharmaceuticals’ Fanapt, originally approved in 2009 for schizophrenia, is now authorized to treat manic or mixed episodes in adults with bipolar I disorder.
Tuesday’s approval is backed by data from a Phase III trial comprising around 400 patients with a history of bipolar I disorder who are currently suffering from a manic episode. Treatment with Fanapt led to significantly…
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Dog (Training) Days of Summer: CU Anschutz Hosts K-9 Explosion-Detection Exercise
Their names could fill in the most adorable starting nine in a baseball lineup – Rony, Scout, Oly, Kaiser, Max, Lani, Jet, Reece and Wolfgang. Click here to view original post
Biodesix Completes Enrollment of INSIGHT Study Assessing Clinical Utility of the VeriStrat® Blood-Based Host Immune Classifier
BOULDER, Colo.–(BUSINESS WIRE)—- $BDSX #patientsfirst–Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, announced today that the large multi-center observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat® […]
Student Baker Hopes to ‘Take the Cake’ on ‘The Great Canadian Baking Show’
In her unexpected role as a reality TV star, Sydney Hayden has already risen to the occasion. As a contestant on “The Great Canadian Baking Show,” the first-year graduate student traded her anatomy books for […]
