Hosted on MSN17h
CHMP recommends AbbVie’s Rinvoq be approved for adult GCA
The treatment has gained approval in the European Union (EU) for a range of conditions, including psoriatic arthritis, ...
Daily16h
Biological E collaborate with Bavarian Nordic to expand Chikungunya Vaccine access in low, middle income countries
Hyderabad: Biological E. Limited has announced a strategic partnership with Bavarian Nordic A/S to expand access to Bavarian ...
Santé log22h
CHMP recommends EU approval of Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
If approved, this off-the-shelf, fixed-duration Columvi combination will be the first bispecific antibody regimen available for patients with DLBCL following relapse ...
centerforbiosimilars5h
Biosimilars Regulatory Roundup: February 2025
February brought policy updates and several biosimilar approvals, including the first FDA approval for an insulin aspart ...
Novartis21h
Novartis oral Fabhalta® (iptacopan) receives positive CHMP opinion for the treatment of adults living with C3 glomerulopathy (C3G)
About Fabhalta® (iptacopan) Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway 6-7.
Santé log22h
TREMFYA® (guselkumab) receives positive CHMP opinion for treatment of adult patients with moderately to severely active ulcerative colitis
Developed by Johnson & Johnson, guselkumab (GUS) is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.