Sanofi gets priority review for its multiple sclerosis treatment by FDA
Sanofi (NASDAQ:SNY) said on Tuesday that the US FDA has granted priority review to the regulatory submission of tolebrutinib ...
Managed Healthcare Executive6h
FDA Grants Priority Review BLA for Spinal Muscular Atrophy Drug, Apitegromab
A Prescription Drug User Fee Act (PDUFA) target action date for apitegromab has been set for Sept. 22, 2025.
Applied Clinical Trials Online12h
Results of Phase III HERCULES, GEMINI 1 and 2 Trials Lead to FDA Priority Review for Tolebrutinib for Non-Relapsing Secondary Progressive MS
FDA grants Priority Review status to Sanofi's tolebrutinib for the treatment of non-relapsing secondary progressive multiple ...
Press Release: Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis
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 ...
Medical Dialogues19h
Sanofi Tolebrutinib under USFDA priority review for multiple sclerosis
Tolebrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory ...
Capricor projects FDA priority review decision for deramiocel by August 2025
Q4 2024 Management View CEO Linda Marban highlighted the acceptance by the FDA of Capricor's Biologics License Application (BLA) for deramiocel, targeting treatment of Duchenne muscular dystrophy (DMD ...
The Cardiology Advisor1d
Finerenone Under Review for Patients With Heart Failure and LVEF ≥40%
The FDA has accepted for Priority Review the sNDA for finerenone for heart failure with mildly reduced or preserved ejection fraction.
Seeking Alpha21d
Capricor: Further Value Unlocked With Priority Review Of Deramiocel
I'm happy to report that not only did it complete the rolling BLA submission of Deramiocel, but the FDA accepted the regulatory application with Priority Review with a PDUFA target action date of ...
pharmaphorum2d
AZ buys cut price priority review voucher, but for what?
AstraZeneca has bought a priority review voucher (PRV) from Swedish biotech Sobi for $95 million, but isn’t revealing just yet what it intends to use it for. A PRV can be used to reduce an FDA ...
Monthly Prescribing Reference29d
Gene Therapy Gets Priority Review for Recurrent Respiratory Papillomatosis
A Prescription Drug User Fee Act target date of August 27, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License ...
Cure Today1mon
Zongertinib Receives Priority Review For HER2 Mutant NSCLC
Zongertinib is under FDA priority review for HER2-mutant advanced NSCLC, showing promise as a groundbreaking oral therapy. The phase 1b BEAMION LUNG-1 trial reported a 71% objective response rate and ...
Sanofi: Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis
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 ...