Food and Drug Administration (FDA)
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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.
Catalyst Pharmaceuticals received a positive decision from the 11th Circuit Court of Appeals over a suit against the U.S. FDA’s approval of a competitor’s amifampridine product.
The Phase III trial on a potential treatment for mild-to-moderate COVID-19 symptoms by Merck and Ridgeback Biotherapeutics showed promise in preventing hospitalizations and death.
The Pfizer-BioNTech booster shot is now authorized for people over 18 and 65 who are immunocompromised, at high risk due to their work or living situation and front-line healthcare workers.
Ferring Pharmaceuticals today announced positive results across all five of its prospective trials for a live biotherapeutic designed to reduce recurrent C. difficile infection (rCDI).
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.
The announcement came following independent FDA analyses of inspections conducted at the two CROs in November 2019.
Horizon was adding five new development programs for daxdilimab and dazodalibep. This brings the company’s pipeline to 27 development programs.
Qulipta is the first calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for this indication.
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