Approvals
The incidence of congenital athymia is about 17 to 24 lives births each year in the U.S. The therapy is a one-time regenerative tissue-based therapy.
Roche’s candidate drug for Alzheimer’s treatment received breakthrough therapy designation which has increased its chance of getting full FDA approval.
If authorized, it could be available in the U.S. before the end of the year. It is also working to submit applications to other regulators worldwide.
The FDA approved ChemoCentryx’s Tavneos (avacopan) as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).
Based on results from the Phase II and Phase III TAK-620-303 (SOLSTICE) trials, members of the AMDAC unanimously voted in favor of using maribavir.
There is — still — plenty of news about COVID-19 and new drugs, therapies and FDA applications. Here’s a look.
The FDA granted the latest designation based on the Phase III DESTINY-Breast03 trial on adult patients diagnosed with unresectable or metastatic HER2-positive breast cancer.
The U.S. FDA is kicking off the month of October with a number of PDUFA dates and an advisory committee meeting. Read on for more details.
LIVMARLI is indicated for ages one year and older and will now be accessible to patients with a prescription through Mirum Access Plus. Here’s more about it.
Qulipta is the first calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for this indication.
PRESS RELEASES