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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Here’s a look at some of the top COVID-19-related stories for today.
Although the COVID-19 pandemic is waning in the U.S., it’s not completely over and there are some concerns, particularly with the delta variant, which originated in India. Here’s a look.
The House Committee on Oversight and Reform announced plans to investigate the approval and pricing of the drug. Biogen, on its part, has defended its pricing.
Adamis has sent a letter to stockholders urging them to re-elect all the five board members as part of a strategic move to continue and maintain its current growth initiatives.
Ahead of the July Fourth holiday, the U.S. Food and Drug Administration has two PDUFA dates on the calendar. Here’s a look.
The U.S. Food and Drug Administration (FDA) has made the decision to grant Breakthrough Therapy Designation to Mirati Therapeutics’ adagrasib for the potential treatment of non-small cell lung cancer (NSCLC) in patients harboring the KRASG12C mutation after systemic therapy.
The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration (FDA), has voted 13-to-4 against supporting the accelerated approval of Incyte’s PD-1 inhibitor for squamous cell carcinoma.
New data continues to emerge that seems to add to the possibility of COVID-19 originating from a lab leak at China’s Wuhan Institute of Virology.
Concerns over vaccination links to heart inflammation are valid, a U.S. Centers for Disease Control and Prevention advisory committee announced this afternoon.
The drug was approved on June 7 under the agency’s accelerated approval pathway, despite the agency’s Peripheral and Central Nervous System Drugs Advisory Committee voting against the drug in November 2020 and having been assured at that time the agency was not considering an accelerated approval.