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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Myovant’s oral Orgovyx beat out Abbvie’s injectable Lupron in achieving medical castration levels in patients. Here is the timeline of the approval.
The FDA put a clinical hold on UniQure’s Phase III trial after a high-risk participant developed liver cancer.
The company and Operation Warp Speed began distribution of the vaccine through McKesson, along with United Parcel Services and FedEx, over the weekend. The first vaccinations are expected today.
In their first appearance in years, the notorious Sackler family, who previously headed OxyContin maker Purdue Pharma, apologized to victims of the opioid crisis but stopped short of admitting personal responsibility during a nearly four-hour grilling from the U.S. House Oversight and Reform Committee.
The U.S. FDA is plenty busy with COVID-19 vaccine Emergency Use Authorizations this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. Here’s a look.
It seems like history is repeating itself from just a week ago. Yesterday, the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the agency grant Moderna’s COVID-19 vaccine emergency use authorization (EUA).
The U.S. Food and Drug Administration (FDA) had several approvals this week. Read on to see what the regulatory agency gave the go-ahead to.
Applications include a nasal COVID-19 vaccine, an NSCLC drug, respiratory infection drug and a treatment for a chronic inflammation of the esophagus.
A critical vote is set to take place today amongst those on a U.S. Food and Drug Administration advisory panel in regard to the COVID-19 vaccine from Moderna.
The U.S. Food and Drug Administration has authorized the first non-prescription, over-the-counter, at-home antigen test that can be used to identify infection with SARS-CoV-2, the virus responsible for COVID-19, in people two years of age or older.