Approvals
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.
The U.S. Food and Drug Administration is wrapping up the end of September and beginning October with two PDUFA dates. Here’s a look.
A day after the FDA authorized a COVID-19 booster dose of the Pfizer-BioNTech vaccine, a U.S. Centers for Disease Control and Prevention advisory committee voted in support.
The approval is based on its Phase III REACH3 trial, which evaluated Jakafi versus the best available therapy for treating chronic GVHD after allogeneic stem cell transplantation.
FDA authorizes Pfizer-BioNTech COVID-19 booster shots for individuals 65 and over, those at high risk for severe disease and front-line healthcare workers.
FDA approved Incyte’s Opzelura (ruxolitinib) cream for atopic dermatitis (AD) for the short-term and non-continuous chronic treatment of mild to moderate AD.
PRESS RELEASES