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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Kite Pharma, a subsidiary of Gilead, announced that its Yescarta® has been approved by the U.S. Food and Drug Administration (FDA).
Mavacamten is often referred to as “first-in-class” because it addresses the root cause of obstructions. Here’s everything you should know about its recent progress.
After wrapping up March with a flurry of PDUFA dates, the U.S. Food and Drug Administration has a more leisurely calendar for the first three weeks of April, at least in terms of drug approvals.
Ishtiaq Ali Saaem is sentenced to three years of probation following a guilty plea to charges he obstructed a federal investigation into his efforts to acquire the deadly toxin ricin.
In a meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, six members voted not to approve the NDA for Amylyx’s ALS candidate, AMX0035, while four voted in favor.
Although it looks that we’re on the downside of the COVID-19 pandemic in the U.S., biopharma companies are still working on developing better treatments and preventions.
Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth booster shot for everyone 50 years of age and older.
Antares Pharma has announced that the U.S. Food and Drug Administration has granted approval to its therapeutic Tlando intended for testosterone replacement therapy (TRT).
Pfizer stated that etrasimod patients achieved statistically significant improvements in primary endpoints of clinical remission and attained all secondary endpoints vs. placebo.
When ImmunoGen announced top-line results from the Phase III SORAYA trial in November 2021, the primary endpoint - confirmed objective response rate - was met at 32.4%.