Cellares, the first Integrated Development and Manufacturing Organization (IDMO), proudly announces that its Cell Shuttle™ ...

Emrosi™ approved by FDA for the treatment of inflammatory lesions of rosacea in adults, with commercial launch underway; initial distribution ...

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.

The approval follows the December 2024 priority review designation for this perioperative immunotherapy regimen for patients fighting muscle-invasive bladder cancer (MIBC).

Apitegromab, a fully human monoclonal antibody, works by selectively binding to the pro- and latent forms of myostatin in order to inhibit myostatin activation.

FDA grants Priority Review status to Sanofi's tolebrutinib for the treatment of non-relapsing secondary progressive multiple ...

Sanofi (NASDAQ:SNY) said on Tuesday that the US FDA has granted priority review for the regulatory submission of tolebrutinib for the treatment of multiple sclerosis. According to the French ...

A Prescription Drug User Fee target date of September 28, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug ...

Sanofi’s tolebrutinib has been accepted for priority review by the US Food and Drug Administration (FDA) to treat certain cases of multiple sclerosis (MS). The investigational drug has been granted ...

A centre dedicated to advocacy for children should be created as part of a re-examination of the Children Act 1998 that was ...

Explore Q1 2025's biotech stock moves, from CervoMed's 300% surge to Septerna's struggles. Click for my review of the quarter ...