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Lundbeck revealed that its migraine drug Vyepti failed to demonstrate statistical superiority over placebo at reducing the number of monthly migraine days.
The FDA’s decision on Axsome Therapeutics’ Auvelity is based on positive results from a massive clinical program that covered over 1,100 patients with depression.
The regulatory path for companies developing drugs for rare diseases is often fraught with challenges. KemPharm CEO Travis Mickle discussed just some of these with BioSpace.
Curis announced that the FDA has allowed patient enrollment to resume in the monotherapy phase of its TakeAim Leukemia Phase I/II trial studying emavusertib.
Cassava Sciences has been informed by the Journal of Prevention of Alzheimer’s Disease that there is no evidence to support the charges, the company said Thursday.
This week’s Movers & Shakers include Arvinas, Inspire and Cambridge Isotope Laboratories all announcing new VP roles, and several others tap new C-suite executives.
A fat hormone that slows liver tumor growth, a genetic map to track tumorigenesis, study that shows we inherit more than expected epigenetic information from our mothers, Alzheimer linked APOE gene protects against glaucoma.
A trial evaluating generic drugs against severe COVID-19 provided data showing their overall ineffectiveness, and COVID-19-related lawsuits continue to pile up.
CDC director Dr. Rochelle Walensky announced plans to launch a “reset” of the agency amid criticism over its handling of the COVID-19 pandemic and other public health threats.
South Korea-based Genuv Inc. announced the publication of a preclinical study showing the potential of Mekinist, approved by the FDA for melanoma, in Alzheimer’s disease.
Jazz Pharma is breaking new ground with its cannabidiol epilepsy treatment Epidiolex, taking the drug into a Phase III study in children and adolescents.
Genentech has partnered with Jemincare to develop and commercialize an asset that may provide new treatment options for people with advanced-stage prostate cancer.