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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The FDA granted the designation based on data from a mid-stage trial that examined the safety and efficacy of Esbriet in this indication.
This approval marks the first time in a decade Sanofi has had a wholly-owned cancer drug approved.
The U.S. Department of Justice charged New Jersey-based Sandoz with four counts of conspiring to rig bids and fix prices for generic drugs.
Five years after Martin Shkreli rose to infamy for acquiring the toxoplasmosis treatment Daraprim from Impax Laboratories for $55 million and then jacking the price by 5,000%, the U.S. FDA approved the first generic for the medication.
The novel coronavirus that causes the disease COVID-19 continues to spread and has now been diagnosed in more than 50 countries.
The green light from the U.S. Food and Drug Administration marks the first approval for U.K.-based Acacia.
Eli Lilly’s Cyramza appears to be on its way to picking up its sixth approval from the U.S. Food and Drug Administration as a treatment for some lung cancer patients following narrow support from an advisory committee.
Nexlizet is expected to be on the market in the U.S. in July 2020.
Kiadis Pharma N.V. announced the launch of a first-in-human clinical trial in patients with relapsed/refractory acute myeloid leukemia with off-the-shelf Natural Killer cells manufactured using Kiadis’ FC21 mbIL21 feeder cells and proprietary universal donor platform.
A federal judge has ruled that a decade’s worth of unpublished clinical trial data from drug companies, universities and other agencies involved, must now be made public.