Sanofi (NASDAQ:SNY) said on Tuesday that the US FDA has granted priority review to the regulatory submission of tolebrutinib ...
A decision on tolebrutinib for treating MS is now set for Sept. 28, after the FDA granted priority review to its approval ...
A Prescription Drug User Fee Act (PDUFA) target action date for apitegromab has been set for Sept. 22, 2025.
Apitegromab, a fully human monoclonal antibody, works by selectively binding to the pro- and latent forms of myostatin in order to inhibit myostatin activation.
Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to ...
(RTTNews) - Sanofi (SNY), a French pharmaceutical and healthcare company, announced Tuesday that the US Food and Drug Administration is evaluating under priority review the regulatory submission ...
Southwest Rapid Rewards Priority Credit Card Introduction The Southwest Rapid Rewards® Priority Credit Card packs plenty of perks. If you’re considering applying for it, here’s the most ...
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for finerenone for the treatment of adult patients with heart failure (HF ...
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the third quarter of 2025. The priority review from the FDA usually brings down the review ...