FDA rejects Vanda’s jet lag drug in current form

Vanda strongly disputes the FDA’s reasoning

Alembic announces USFDA tentative approval for Bosutinib tablets

Novartis to open Florida radioligand facility

New 35,000-square-foot facility in Winter Park will expand RLT manufacturing footprint to optimize delivery for patients across southeastern US

Nxera secures exclusive APAC rights to DMD drug Vamorolone in deal with Santhera

Nxera will take full responsibility for regulatory approvals, clinical development where required, manufacturing and commercialization in the licensed territories

Revvity and Lilly partner to accelerate AI drug discovery models

Collaboration funds participating biotechs to access Lilly predictive models through the Revvity Signals Xynthetica offering

Rapid-acting ADHD treatment Azstarys now approved in China

ADHD is a common, chronic neurodevelopmental disorder that often begins in childhood and can persist into adulthood

Alzheimer’s could soon be detected with a simple finger-prick

Blood tests measuring biomarkers such as p-tau217 are emerging as accurate, accessible alternatives

FDA grants priority review to Tzield for youngest Type 1 diabetes patients

Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D

Incyte eyes first-line nod for Tafasitamab in aggressive lymphoma

Diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL) in adults, represents 40% of all cases worldwide

WuXi Biologics secures ISO 20400 certification

WuXi Biologics has integrated sustainability principles throughout its supplier lifecycle management