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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Pfizer is lining up a potential New Drug Application for an ulcerative colitis treatment for patients who are not seeing an improvement in their condition from currently available options.
Moderna reported positive interim results from the Phase II/III KidCOVE trial of its mRNA COVID-19 vaccine for children six months to under two years and two to six years of age.
Like Elizabeth Holmes, Ramesh Balwani faces multiple counts of fraud related to the business practices of Theranos.
Teva Pharmaceuticals and AbbVie will pay the state of Rhode Island a combined $28.5 million to settle opioid-related claims against the companies.
Takeda faces yet another setback by the U.S. Food and Drug Administration for its parathyroid hormone, natpara.
Who is to thank for the COVID vaccine? Many major biopharma companies are asking that question after a series of lawsuits over patent rights to the vaccine and its associated technology.
An FDA Investigational New Drug application has been approved for NeuroSense Therapeutics Ltd.’s PrimeC, a potential therapeutic targeting amyotrophic lateral sclerosis (ALS).
Russia’s continued assault on Ukraine threatens a supply of chemicals and compounds that drug researchers and developers use across the globe.
Provention Bio has announced that the FDA has accepted its biologics license application resubmission for teplizumab, a drug intended to delay clinical Type I Diabetes (T1D) in at-risk individuals.
Albert Bourla, Pfizer’s CEO, took home a salary of $1.69 million in 2021. To Pfizer, he’s undoubtedly worth it, having led the company to its COVID-19 vaccine success.