A final decision is expected by the pdufa (prescription drug user fee act) date of october 25, 2025. The fda has set a prescription drug user fee act (pdufa), or target action date, of oct. Access our free pdufa calendar to track upcoming pdufa dates, fda approval dates, and biotech catalysts.
Zenith was the first phase 3 pah.
Winrevair has shown a 76% reduction in. “we are pleased that the fda has accepted our sbla for winrevair. Food and drug administration (fda) has accepted for priority review merck’s new biologics license application (bla) for sotatercept, an activin signaling inhibitor,. Joerg koglin, senior vice president of global clinical development at.
The regulatory agency has assigned a prescription drug user fee act target action date of october 25, 2025. Mrk), known as msd outside of the united states and canada, announced today that the u.s. The sbla is based on data from the phase 3 zenith trial. Updated daily, it includes pdufa dates for 2025.
Currently, sotatercept has a prescription drug user fee act (pdufa) date of october 25, 2025.
The sbla is based on data from the phase 3 zenith trial. The agency is missing deadlines and not responding to biotech companies, forcing some to push back clinical trials. The fda has set a prescription drug user fee act (pdufa), or target action date, of oct. Announced by parent company merck on july 2, 2025, the sbla submission was based on positive results from the phase 3 zenith trial.
