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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Companies across Europe and Asia provide information about deal, clinical trials and more, with news from Synaptive Medical, Epic, Inventiva, Velabs, and more.
One of the criticisms of the biopharma industry—at least in the context of drug pricing—is how much the industry as a whole spends on lobbyists. For example, last year, PhRMA, the industry lobbying group, spent more than $27.5 million on its lobbying activities.
The government said the executives and the company failed to comply with its legal obligation to report thousands of suspicious orders of controlled substances to the DEA.
FDA
Plaque psoriasis is the most common type of psoriasis, caused by overproduction of skin cells. This causes inflamed, red lesions called plaques.
GenFit’s lead product candidate elafibranor snagged Breakthrough Therapy Designation from the U.S. Food and Drug Administration as a treatment for Primary Biliary Cholangitis (PBC) following strong Phase II results that demonstrated the safety and efficacy of the medication.
The rival developer appealed the recently approved 150,000 square foot development, saying it would shrink the amount of space between buildings.
Over the past few years there seems to be a growing number of people in the United States who, for a myriad of reasons, opt out of vaccinating their children against common pathogens that often have deadly effects – like the measles.
Obesity can break down our protective blood brain barrier resulting in problems with learning and memory, scientists report.
Steps have been taken to safeguard the cancer center, including development of a cutting-edge approach to Enterprise Risk Management.
FDA
Renal cell carcinoma is also called renal cell cancer or renal cell adenocarcinoma. Approximately 90% of all kidney cancers are renal cell carcinomas.