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 DSMB for Ocugen’s Phase I/II trial of OCU400, a gene therapy in development for Retinitis Pigmentosa (RP), recommended the study proceed with enrolling more patients.
Shares of Axsome Therapeutics have fallen more than 20% in trading this morning after the company announced the FDA is unlikely to approve its acute migraine treatment AXS-07 due to unresolved quality control issues.
Final analysis of the Himalaya trial demonstrated safety as well as a statistically relevant 22% improvement of overall survival (OS) without exposing the patient to an increase in liver toxicity.
Patient deaths associated with Astellas Pharma’s gene therapy candidate underscore the risks of developing potential one-and-done treatment options for serious diseases.
WHO is raising flags against the concerns surrounding a mysterious illness (related to pediatric liver disease) that is increasing following a reported death.
One of the most common types of leave is family leave, and navigating it can be a long, arduous process. To help, we’ve created a guide to answer your questions about family medical leave.
Nkarta announced that two of its therapies have shown complete remission in patients with blood cancer. These results are the latest development in the treatment of difficult-to-treat blood cancers.
Ardelyx announced the FDA’s OND, CDER, provided an interim response to the company’s second level of appeal for tenapanor. Here’s what you need to know.
Today, Astellas announced that after evaluating its gene therapy for patients with X-linked Myotubular Myopathy, it revised its eligible treatment population and any likely future product label.
Louisiana Attorney General Jeff Garland sued UnitedHealth Group over Medicaid fraud. In a lawsuit filed earlier this week, Garland alleged the insurance company overinflated drug charges.