GSK’s Nucala receives European Commission approval to treat chronic obstructive pulmonary disease
Nucala is the first and only monthly biologic in the EU evaluated in a wide COPD population with an eosinophilic phenotype
Nucala is the first and only monthly biologic in the EU evaluated in a wide COPD population with an eosinophilic phenotype
HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
The study tested whether PF’3944 could maintain efficacy when switching from weekly to monthly injections and remain safe and well-tolerated
Glucon-D maintained its leadership position with a 59% MAT market share
The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa
Subscribe To Our Newsletter & Stay Updated