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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Attorneys for Holmes have speculated that the lab failures at Theranos are the fault of Rosendorf and not Holmes herself.
Moderna seeks to invalidate two patents of Arbutus Biopharma Corp. The company hopes to appeal a preemptive challenge to the patents upheld by the U.S. Patent Trial and Appeals Board.
Henrietta Lacks’ family accuses Thermo Fisher Scientific of profiting off the first cell line that had been shared and replicated in a lab for the development of countless medical innovations.
After serving three presidential administrations, Dr. Francis S. Collins is stepping down as director of the National Institutes of Health at the end of the year.
The DOL’s Office of Federal Contract Compliance Programs found that AstraZeneca paid a much lower base salary than similar employees to 23 Hispanic female staff and 295 female employees.
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 Pfizer-BioNTech booster shot is now authorized for people over 18 and 65 who are immunocompromised, at high risk due to their work or living situation and front-line healthcare workers.
Jose Luis Casero Sanchez took advantage of his position in Goldman Sachs’ “control room” to gain insider knowledge of upcoming transactions, including those for several biopharma companies.
Teva Pharmaceuticals reached a $15 million agreement with the state of Louisiana to settle claims against the company over its marketing of opioid products.