Regulatory
Acting FDA Commissioner Janet Woodcock’s days as interim head of the agency are numbered due to federal regulations. Speculations are rampant on a number of potential choices.
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 announcement came following independent FDA analyses of inspections conducted at the two CROs in November 2019.
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.
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