Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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News on COVID-19 vaccine developments and disease studies continue to deliver highs and lows. Here are some of the more recent happenings.
The beginning of booster vaccines for adults was in news for a long time. Well, CDS authorized it now, and here’s the reason behind the authorization.
A Chinese professor at the University of Copenhagen in Denmark is under scrutiny over undisclosed ties to the Chinese military.
BioMarin Pharmaceutical scored a first on Friday and provided an option for patients with a rare disease for which there is little recourse.
The two dominant theories over the origins of COVID-19 are that the virus developed naturally, probably from bats in a wet market in Wuhan, China, and the “lab leak.”
The U.S. Food and Drug Administration approved COVID-19 vaccine booster shots for all Americans ages 18 and over Friday morning.
While COVID-19 appears to be battling back in cold-weather states in the U.S. and parts of Europe, researchers continue to study vaccine efficacy and new approaches to dosing. Here’s a look.
The FDA and CDC will soon decide on Pfizer-BioNTech’s request for an Emergency Use Authorization for the booster shot for their COVID-19 vaccine.
The U.S. Securities and Exchange Commission has launched an investigation into Texas-based Cassava Sciences.
Iterum Therapeutics will head back into the clinic to meet regulatory requirements to refile a New Drug Application for oral sulopenem.