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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Heading into the middle of January, companies announced plenty of new clinical trial news. Here’s a look.
Former Food and Drug Commissioner Robert Califf is one step closer to returning to his old office after the Senate Health, Education, Labor and Pensions Committee advanced his nomination.
Researchers from the Medical University of Bialystok in Poland identified a gene that appears to double the risk of severe COVID-19.
NRx is seeking $185 million in damages and claims that Relief has breached the collaboration agreement established in 2020 regarding the development of the COVID-19 drug, aviptadil.
PCN-101 was recently awarded Investigational New Drug (IND) status by the U.S. Food and Drug Administration. It’s a for treating the patients with treatment resistant depression.
According to the Environmental Litigation Group, P.C., approximately 37.5% of all occupational lung cancer cases are related to occupational asbestos exposure.
The Centers for Medicare and Medicaid Services indicated it would cover the cost of these drugs and any necessary scans — but only “if they are enrolled in qualifying clinical trials.”
Pfizer has reported that an Omicron-specific vaccine will be available in March, should it be necessary. For those and more COVID-19 news, continue reading.
The U.S. averages more than 700,000 new COVID-19 cases per day. As of Saturday, there were 4.91M cases, more cases in seven days than in April, May, June, and July 2021 combined.
Judge Mark Pittman found that the Freedom of Information Act filed by PHMPT is of paramount public importance and demands that the FDA make the data publicly available within eight months.