PDUFA

FDA stop sign
Biotech

FDA delays decision on Stealth's ultrarare disease med

It looks like Stealth will have to remain patient a while longer before it finally finds out whether its Barth syndrome treatment will be approved.
James Waldron Jan 23, 2025 9:45am
Delayed on hold

FDA delays decision on Moderna's RSV shot until the end of May

May 10, 2024 10:30am
delay FDA delay

Applied Tx’s pediatric rare disease prosect hits another snag

Mar 29, 2024 10:21am
journey path light sunshine stairs climb reach

Karuna's schizophrenia drug set for FDA decision in Q3 2024

Nov 29, 2023 10:00am
valneva

FDA delays decision on Valneva's chikungunya vaccine by 3 months

Aug 14, 2023 6:00am
race track

GSK's RSV shot rises over peers with expected May FDA decision

Nov 2, 2022 10:06am