BREAKING NEWS: The FDA has approved Gazyva® (obinutuzumab) for the treatment of adults with #lupus nephritis. Gazyva is the fourth therapy for lupus to receive regulatory approval since 2011.
Read the announcement: buff.ly/81tYgo7
Read the announcement: buff.ly/81tYgo7
October 20, 2025 at 1:02 PM
BREAKING NEWS: The FDA has approved Gazyva® (obinutuzumab) for the treatment of adults with #lupus nephritis. Gazyva is the fourth therapy for lupus to receive regulatory approval since 2011.
Read the announcement: buff.ly/81tYgo7
Read the announcement: buff.ly/81tYgo7
Obinituzumab aka ‘Obi’ is now FDA approved for lupus nephritis
finance.yahoo.com/news/fda-app...
#lupus
finance.yahoo.com/news/fda-app...
#lupus
FDA Approves Genentech’s Gazyva for the Treatment of Lupus Nephritis
SOUTH SAN FRANCISCO, Calif., October 20, 2025--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Gazyva...
finance.yahoo.com
October 20, 2025 at 11:14 AM
Obinituzumab aka ‘Obi’ is now FDA approved for lupus nephritis
finance.yahoo.com/news/fda-app...
#lupus
finance.yahoo.com/news/fda-app...
#lupus
FDA just approved two more treatments: Atebrioz became the third treatment for FOP, while Gazyva was approved for idiopathic nephrotic syndrome in patients age 2 and older
Notable Approvals
News about human drug-related approvals
www.fda.gov
September 27, 2026 at 3:14 PM
FDA just approved two more treatments: Atebrioz became the third treatment for FOP, while Gazyva was approved for idiopathic nephrotic syndrome in patients age 2 and older
A new analysis in @NEJM underscores Gazyva® superiority over standard therapy for active #lupus nephritis (LN). The LFA is proud to have supported this study. Read the announcement:
UPDATE: Gazyva® Shows Superiority Over Standard Therapy for People with Active Lupus Nephritis
The New England Journal of Medicine has published a detailed analysis of Genentech’s positive results from the Phase III REGENCY study of Gazyva® (Obinutuzumab) for people with active lupus nephritis…
buff.ly
February 7, 2025 at 8:26 PM
A new analysis in @NEJM underscores Gazyva® superiority over standard therapy for active #lupus nephritis (LN). The LFA is proud to have supported this study. Read the announcement:
Breaking News! The FDA has accepted Genentech’s Supplemental Biologics License Application for Gazyva for the potential treatment of lupus nephritis (lupus-related kidney disease). Learn more about what this next step means for this potential treatment: buff.ly/6NrcsK3
March 5, 2025 at 2:41 PM
Breaking News! The FDA has accepted Genentech’s Supplemental Biologics License Application for Gazyva for the potential treatment of lupus nephritis (lupus-related kidney disease). Learn more about what this next step means for this potential treatment: buff.ly/6NrcsK3
Nulojix, Benlysta, Zinbryta, Darzalex, Erelzi, Zarxio, Voraxaze, Extavia, Myalept, Portrazza, Gazyva, Arzerra, Vectibix, Krystexxa, Cyramza, Cosentyx,
February 14, 2025 at 4:59 AM
Nulojix, Benlysta, Zinbryta, Darzalex, Erelzi, Zarxio, Voraxaze, Extavia, Myalept, Portrazza, Gazyva, Arzerra, Vectibix, Krystexxa, Cyramza, Cosentyx,
The FDA expanded the indications for the B-cell depleter obinutuzumab (Gazyva) to include idiopathic nephrotic syndrome, the agency announced on Friday, the first new option for the rare kidney disease in more than half a century.
https://www.medpagetoday.com/nephrology/generalnephrology/123168
https://www.medpagetoday.com/nephrology/generalnephrology/123168
First New Drug Approved for Idiopathic Nephrotic Syndrome in 70 Years
Anti-CD20 agent obinutuzumab (Gazyva) gets green light for patients as young as 2 years
www.medpagetoday.com
September 28, 2026 at 5:55 PM
The FDA expanded the indications for the B-cell depleter obinutuzumab (Gazyva) to include idiopathic nephrotic syndrome, the agency announced on Friday, the first new option for the rare kidney disease in more than half a century.
https://www.medpagetoday.com/nephrology/generalnephrology/123168
https://www.medpagetoday.com/nephrology/generalnephrology/123168
FDA Approves Gazyva® (obinutuzumab) for the Treatment of Adults with Lupus Nephritis
www.lupus.org/news/fda-app...
@lupus.org
www.lupus.org/news/fda-app...
@lupus.org
FDA Approves Gazyva® (obinutuzumab) for the Treatment of Adults with Lupus Nephritis
The U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab), developed by Genentech, as a treatment for adults with lupus nephritis (LN), also known as lupus-related kidney disease...
www.lupus.org
November 13, 2025 at 3:48 PM
FDA Approves Gazyva® (obinutuzumab) for the Treatment of Adults with Lupus Nephritis
www.lupus.org/news/fda-app...
@lupus.org
www.lupus.org/news/fda-app...
@lupus.org
Also interesting that both of these, PML and Hep B, are noted on the Gazyva website. Different dosing for lymphoma?
March 12, 2025 at 2:15 AM
Also interesting that both of these, PML and Hep B, are noted on the Gazyva website. Different dosing for lymphoma?
I've tried some on your list. I tried many before I finally got cellcept approved. Insurance made me. Now they pay even more towards my treatment because they wouldn't approve the low dose I needed at the time.😵💫 I'm glad Gazyva came out bc my doc told me there were no other options. I hate lupus.
September 30, 2026 at 12:32 AM
I've tried some on your list. I tried many before I finally got cellcept approved. Insurance made me. Now they pay even more towards my treatment because they wouldn't approve the low dose I needed at the time.😵💫 I'm glad Gazyva came out bc my doc told me there were no other options. I hate lupus.
" #Obinutuzumab ( #Gazyva ) appears set to add systemic #lupus erythematosus ( #SLE ) to its list of approved indications, as results from a phase III trial showed it was significantly more effective than placebo, with no new safety concerns.": buff.ly/WWFikk5
via @medpagetoday.com
#BCell #MedSky
via @medpagetoday.com
#BCell #MedSky
Another B-Cell Drug for Lupus Hits the Mark
Phase III results put obinutuzumab in line for approval
buff.ly
March 7, 2026 at 9:30 AM
" #Obinutuzumab ( #Gazyva ) appears set to add systemic #lupus erythematosus ( #SLE ) to its list of approved indications, as results from a phase III trial showed it was significantly more effective than placebo, with no new safety concerns.": buff.ly/WWFikk5
via @medpagetoday.com
#BCell #MedSky
via @medpagetoday.com
#BCell #MedSky
What my bio dad always said before he passed. He was my best advocate. If it wasn't for my puppy, I don't know... I took this little dude with me and dared anyone to say something, but everybody melted over him lol
Ugh, I'm so stressed and SCARED! I have NO immune system. I started gazyva in April
Ugh, I'm so stressed and SCARED! I have NO immune system. I started gazyva in April
September 29, 2026 at 10:15 PM
What my bio dad always said before he passed. He was my best advocate. If it wasn't for my puppy, I don't know... I took this little dude with me and dared anyone to say something, but everybody melted over him lol
Ugh, I'm so stressed and SCARED! I have NO immune system. I started gazyva in April
Ugh, I'm so stressed and SCARED! I have NO immune system. I started gazyva in April
FDA Approves Roche’s Gazyva/Gazyvaro For The Treatment Of Lupus Nephritis
www.roche.com/media/releas...
www.roche.com/media/releas...
FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in phase II NOBILITY and phase III REGENCY data1,2Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibod...
www.roche.com
October 20, 2025 at 2:08 PM
FDA Approves Roche’s Gazyva/Gazyvaro For The Treatment Of Lupus Nephritis
www.roche.com/media/releas...
www.roche.com/media/releas...
FDA approved Gazyva on 25 Sep to cut relapse risk in childhood nephrotic syndrome (age 2+, in remission). Boxed warning: hep B and PML.
https://americapharmatoday.com/news/fda-approves-gazyva-idiopathic-nephrotic-syndrome?utm_source=bluesky&utm_medium=social&utm_campaign=gazyva-ins-20260925
#FDA
https://americapharmatoday.com/news/fda-approves-gazyva-idiopathic-nephrotic-syndrome?utm_source=bluesky&utm_medium=social&utm_campaign=gazyva-ins-20260925
#FDA
FDA approves Gazyva for nephrotic syndrome relapse — America Pharma Today
FDA approved Gazyva on 25 Sep 2026 to reduce relapse in childhood-onset idiopathic nephrotic syndrome. The label has a boxed warning.
americapharmatoday.com
September 26, 2026 at 7:24 PM
FDA approved Gazyva on 25 Sep to cut relapse risk in childhood nephrotic syndrome (age 2+, in remission). Boxed warning: hep B and PML.
https://americapharmatoday.com/news/fda-approves-gazyva-idiopathic-nephrotic-syndrome?utm_source=bluesky&utm_medium=social&utm_campaign=gazyva-ins-20260925
#FDA
https://americapharmatoday.com/news/fda-approves-gazyva-idiopathic-nephrotic-syndrome?utm_source=bluesky&utm_medium=social&utm_campaign=gazyva-ins-20260925
#FDA
FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
I hope there are still people to review this!
I hope there are still people to review this!
FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal response benefit1 The filing application is based on data from the phase…
buff.ly
March 5, 2025 at 8:21 PM
FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
I hope there are still people to review this!
I hope there are still people to review this!
Phase III ALLEGORY study for Gazyva® (obinutuzumab) shows significant reduction in disease activity in adults with #SLE. The study met all primary and secondary endpoints, showing greater improvements compared to standard therapy.
Read more: buff.ly/dG6PvsJ
Read more: buff.ly/dG6PvsJ
Phase III Study Shows Positive Results for Gazyva® in Systemic Lupus Erythematosus
New results from a study of a drug called Gazyva (obinutuzumab) showed that it significantly reduced disease activity in adults with systemic lupus erythematosus (SLE).
buff.ly
November 5, 2025 at 3:02 PM
Phase III ALLEGORY study for Gazyva® (obinutuzumab) shows significant reduction in disease activity in adults with #SLE. The study met all primary and secondary endpoints, showing greater improvements compared to standard therapy.
Read more: buff.ly/dG6PvsJ
Read more: buff.ly/dG6PvsJ
FDA approved #obinutuzumab #Gazyva for the treatment of #SLE #lupus nephritis when used with other standard therapies!
Complete renal responses: higher than standard therapies.
Studies show deep tissue B-cell depletion.
Complete renal responses: higher than standard therapies.
Studies show deep tissue B-cell depletion.
October 20, 2025 at 6:22 PM
FDA approved #obinutuzumab #Gazyva for the treatment of #SLE #lupus nephritis when used with other standard therapies!
Complete renal responses: higher than standard therapies.
Studies show deep tissue B-cell depletion.
Complete renal responses: higher than standard therapies.
Studies show deep tissue B-cell depletion.
The B-cell depleting agent obinutuzumab (Gazyva) was superior to the immunosuppressant tacrolimus in inducing remissions in primary membranous nephropathy, the global phase III MAJESTY trial showed.
https://www.medpagetoday.com/meetingcoverage/era/121618
https://www.medpagetoday.com/meetingcoverage/era/121618
B-Cell Depleter Nabs Phase III Win in Autoimmune Kidney Disease
Obinutuzumab tops immunosuppressant tacrolimus for membranous nephropathy remissions
www.medpagetoday.com
June 8, 2026 at 2:13 AM
The B-cell depleting agent obinutuzumab (Gazyva) was superior to the immunosuppressant tacrolimus in inducing remissions in primary membranous nephropathy, the global phase III MAJESTY trial showed.
https://www.medpagetoday.com/meetingcoverage/era/121618
https://www.medpagetoday.com/meetingcoverage/era/121618
We'd like to thank our #LupusAwarenessMonth sponsor, Gazyva! 💜 Their support helps us #MakeLupusVisible this May — from raising #lupus awareness to advancing research and expanding support programs people living with #lupus depend on. We're grateful for their partnership.
May 8, 2026 at 2:02 PM
We'd like to thank our #LupusAwarenessMonth sponsor, Gazyva! 💜 Their support helps us #MakeLupusVisible this May — from raising #lupus awareness to advancing research and expanding support programs people living with #lupus depend on. We're grateful for their partnership.
After 16 years of disappointing Rituxan data, Roche finds success with Gazyva in lupus nephritis and heads to the FDA after a Phase 3 win.
Roche heads to FDA with Gazyva results in a form of lupus
Almost 16 years after Rituxan's disappointing data in lupus, Roche's Genentech found success with a different B cell-killing drug called Gazyva in lupus nephritis — and it’s taking the antibody to ...
endpts.com
February 7, 2025 at 3:30 PM
After 16 years of disappointing Rituxan data, Roche finds success with Gazyva in lupus nephritis and heads to the FDA after a Phase 3 win.
FDA Approves Gazyva® (obinutuzumab) for the Treatment of Adults with Lupus Nephritis.
I´m German, thank God my kidneys still work well, after more than 33 years of lving with #SLE.
(Diagnosed in 2002)
www.lupus.org/news/fda-app...
@lupus.org
I´m German, thank God my kidneys still work well, after more than 33 years of lving with #SLE.
(Diagnosed in 2002)
www.lupus.org/news/fda-app...
@lupus.org
FDA Approves Gazyva® (obinutuzumab) for the Treatment of Adults with Lupus Nephritis
The U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab), developed by Genentech, as a treatment for adults with lupus nephritis (LN), also known as lupus-related kidney disease...
www.lupus.org
October 20, 2025 at 2:43 PM
FDA Approves Gazyva® (obinutuzumab) for the Treatment of Adults with Lupus Nephritis.
I´m German, thank God my kidneys still work well, after more than 33 years of lving with #SLE.
(Diagnosed in 2002)
www.lupus.org/news/fda-app...
@lupus.org
I´m German, thank God my kidneys still work well, after more than 33 years of lving with #SLE.
(Diagnosed in 2002)
www.lupus.org/news/fda-app...
@lupus.org
Roche's anti-CD20 Obinutuzumab gets FDA approval for #Lupus nephritis
#immunology #immunotherapy #autoimmunity
www.roche.com/investors/up...
#immunology #immunotherapy #autoimmunity
www.roche.com/investors/up...
FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in phase II NOBILITY and phase III REGENCY data1,2Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibod...
www.roche.com
October 20, 2025 at 1:05 PM
Roche's anti-CD20 Obinutuzumab gets FDA approval for #Lupus nephritis
#immunology #immunotherapy #autoimmunity
www.roche.com/investors/up...
#immunology #immunotherapy #autoimmunity
www.roche.com/investors/up...