Drug Approval | May 06, 2022
Zydus receives tentative approval from USFDA for Selexipag tablets
The drug will be manufactured at the group's formulation facility at SEZ, Ahmedabad
The drug will be manufactured at the group's formulation facility at SEZ, Ahmedabad
According to the National Institutes of Health, more than six million Americans, most age 65 or older, may have dementia caused by Alzheimer's disease, a brain disorder known to slowly destroy memory and thinking skills
Infigratinib is not FDA-, Health Canada- or Therapeutics Goods Association-approved for any other indication
The announcement follows FDA 510(k) clearance of device
Three RFPs now open for qualified researchers through NORD's Jayne Holtzer rare disease research grants program
Blood test for early detection of Alzheimer's Disease (AD) risk will lead to better patient care, physicians say; US. adults call for earlier evaluation and more education
The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023
The USFDA approval in AS marks the fifth indication for Rinvoq in chronic immune-mediated diseases
The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients
Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks
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