Regulatory
Pfizer and BioNTech share data with FDA on COVID-19 vaccines for younger children as Sanofi pivot on its mRNA COVID-19 vaccine, shifting focus toward other infectious diseases instead.
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.
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.
The company announced Friday that clinical studies have been placed on hold following the development of tumors in mice in a non-clinical study.
The vote to offer a booster to those 65 and older, as well as immunocompromised individuals at high risk of developing severe COVID-19, was a unanimous “yea” at 18-0.
From time to time, the U.S. FDA requests additional data from companies who have submitted an application for a new drug or biologic. What’s a bit unusual is every single PDUFA date this week had that happen.
NTLA-5001 is being developed for the treatment of acute myeloid leukemia (AML).
Amylyx’s decision to submit the NDA, announced Wednesday morning, came on the heels of recent discussions with the FDA, including a pre-NDA meeting held on July 15.
A patient treated with Astellas Pharma’s experimental gene therapy for patients with X-linked Myotubular Myopathy (XLMTM) has died after a serious adverse event following treatment.
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