THE FIRST FDA-APPROVED TREATMENT FOR MY RARE DISEASE IS HERE 😭😭😭 BRO I CANNOT BELIEVE THIS DAY IS HERE 😭😭😭
FDA approves IMAAVY® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a landmark advancement for patients
· IMAAVY is an immunoselective FcRn blocker designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies while also preserving B-cell function · Warm autoimmune hemolytic anemia is a...
www.jnj.com
August 24, 2026 at 11:46 PM
THE FIRST FDA-APPROVED TREATMENT FOR MY RARE DISEASE IS HERE 😭😭😭 BRO I CANNOT BELIEVE THIS DAY IS HERE 😭😭😭
Didn't expect to read this before my coffee got cold! The FDA just approved IMAAVY (nipocalimab) for warm autoimmune hemolytic anemia (wAIHA). That's when your immune system attacks your red blood cells.
FDA Approves IMAAVY® (nipocalimab-aahu) as First-Ever Treatment for Warm Autoimmune Hemolytic Anemia
The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's IMAAVY® (nipocalimab-aahu) for adults and pediatric patients aged 12 and older with warm autoimmune hemolytic anemia (wAIHA
kfgo.com
August 25, 2026 at 2:01 AM
Didn't expect to read this before my coffee got cold! The FDA just approved IMAAVY (nipocalimab) for warm autoimmune hemolytic anemia (wAIHA). That's when your immune system attacks your red blood cells.
🚨‼️👀
Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease.
www.prnewswire.com/news-release...
Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease.
www.prnewswire.com/news-release...
Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease
The Breakthrough Therapy Designation (BTD) for investigational nipocalimab in Sjögren's disease, a prevalent autoantibody disease with no approved advanced...
www.prnewswire.com
November 18, 2024 at 1:33 AM
🚨‼️👀
Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease.
www.prnewswire.com/news-release...
Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease.
www.prnewswire.com/news-release...
The FDA has approved Imaavy (nipocalimab-aahu) for warm autoimmune hemolytic anemia, becoming the first FDA-approved treatment listed for the disease.
Notable Approvals | Drugs
News about human drug-related approvals
www.fda.gov
August 31, 2026 at 4:45 AM
The FDA has approved Imaavy (nipocalimab-aahu) for warm autoimmune hemolytic anemia, becoming the first FDA-approved treatment listed for the disease.
FDA has given FDA Therapy designation to Nipocalimab 4 treatment of adults w/ mod-to-severe Sjögren’s. NIPO is an Ab to neonatal Fc receptor (FcRn), & was tested & shown effective in Sj Phase 2 DAHLIAS study - a plenary presentation at #ACR24. (@RheumNow post) buff.ly/4fwfnuy buff.ly/4fwfpTc
Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease
The Breakthrough Therapy Designation (BTD) for investigational nipocalimab in Sjögren's disease, a prevalent autoantibody disease with no approved advanced...
buff.ly
November 18, 2024 at 1:00 AM
FDA has given FDA Therapy designation to Nipocalimab 4 treatment of adults w/ mod-to-severe Sjögren’s. NIPO is an Ab to neonatal Fc receptor (FcRn), & was tested & shown effective in Sj Phase 2 DAHLIAS study - a plenary presentation at #ACR24. (@RheumNow post) buff.ly/4fwfnuy buff.ly/4fwfpTc
Johnson & Johnson has announced positive topline results from the Phase 2b JASMINE study of nipocalimab for adults living with active lupus, meeting primary endpoints. Read the announcement:
Phase 2b JASMINE trial of nipocalimab demonstrates positive results for treatment of systemic lupus erythematosus
Johnson & Johnson announced positive topline results from its Phase 2 randomized placebo-controlled JASMINE study. The drug therapy, nipocalimab, met its primary endpoint and multiple key secondary…
buff.ly
January 9, 2026 at 7:00 PM
Johnson & Johnson has announced positive topline results from the Phase 2b JASMINE study of nipocalimab for adults living with active lupus, meeting primary endpoints. Read the announcement:
Sjogren's Disease News: Nipocalimab investigational treatment has been granted FDA breakthrough therapy designation and Fast Track designation.
Nipocalimab is a fully human mAb that targets the neonatal crystallizable fragment receptor (FcRn).
#Sjogrens
www.jnj.com/media-center...
Nipocalimab is a fully human mAb that targets the neonatal crystallizable fragment receptor (FcRn).
#Sjogrens
www.jnj.com/media-center...
Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren’s disease, has now receive...
Sjögren’s disease (SjD) is a prevalent, debilitating autoantibody disease with no FDA-approved advanced treatments The Company is actively enrolling patients in the Phase 3 DAFFODIL study This marks t...
www.jnj.com
March 23, 2025 at 6:36 AM
Sjogren's Disease News: Nipocalimab investigational treatment has been granted FDA breakthrough therapy designation and Fast Track designation.
Nipocalimab is a fully human mAb that targets the neonatal crystallizable fragment receptor (FcRn).
#Sjogrens
www.jnj.com/media-center...
Nipocalimab is a fully human mAb that targets the neonatal crystallizable fragment receptor (FcRn).
#Sjogrens
www.jnj.com/media-center...
Update: #EULAR2026 late-breaking results from the Phase 2 JASMINE trial showed significant disease activity reduction with nipocalimab in adults with active #lupus. The findings build on previously reported positive results.
Read the announcement: buff.ly/eQHcgPn
Read the announcement: buff.ly/eQHcgPn
June 3, 2026 at 4:55 PM
Update: #EULAR2026 late-breaking results from the Phase 2 JASMINE trial showed significant disease activity reduction with nipocalimab in adults with active #lupus. The findings build on previously reported positive results.
Read the announcement: buff.ly/eQHcgPn
Read the announcement: buff.ly/eQHcgPn
www.jnj.com/media-center...
📝Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study.
#SLE #phase2
📝Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study.
#SLE #phase2
Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study
The JASMINE study met the primary endpoint and key secondary and exploratory endpoints, including those indicating the potential of nipocalimab for steroid sparing SLE is one of the most prevalent and...
www.jnj.com
January 13, 2026 at 7:30 AM
www.jnj.com/media-center...
📝Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study.
#SLE #phase2
📝Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study.
#SLE #phase2
FDA has granted Fast Track designation to J&Js nipocalimab for use in #SLE based on the results of a Phase 2b JASMINE study in which nipocalimab demonstrated reduction in lupus disease activity and potential for steroid sparing www.jnj.com/media-center...
Johnson & Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE)
Fast Track designation reflects the unmet need in this serious disease and enables the potential for an accelerated FDA review timeline The designation is supported by a Phase 2 study in which…
www.jnj.com
March 4, 2026 at 10:54 PM
FDA has granted Fast Track designation to J&Js nipocalimab for use in #SLE based on the results of a Phase 2b JASMINE study in which nipocalimab demonstrated reduction in lupus disease activity and potential for steroid sparing www.jnj.com/media-center...
J&J announced the FDA jas granted the investigational drug, nipocalimab (FcRn recpt Ab), with Fast Track designation for its study in adult patients with moderate-to-severe Sjögren’s disease buff.ly/SFYky98
March 22, 2025 at 8:00 PM
J&J announced the FDA jas granted the investigational drug, nipocalimab (FcRn recpt Ab), with Fast Track designation for its study in adult patients with moderate-to-severe Sjögren’s disease buff.ly/SFYky98
Nipocalimab (Johnson and Johnson) or Rozanolixizumab (UCB Pharma) have very similar mechanisms and might be options.
January 30, 2025 at 9:31 PM
Nipocalimab (Johnson and Johnson) or Rozanolixizumab (UCB Pharma) have very similar mechanisms and might be options.
#EAN2026 - #Nipocalimab Shows Durable MG‑ADL Gains Across Subgroups In Vivacity‑MG3
www.ipharmacenter.com/post/europea...
#news #media #pharma #pharmaceutical #neurology #europe #healthcare #globalhealth
www.ipharmacenter.com/post/europea...
#news #media #pharma #pharmaceutical #neurology #europe #healthcare #globalhealth
European Academy of Neurology (EAN) Congress 2026 | iPharmaCenter
Nipocalimab Shows Durable MG‑ADL Gains Across Subgroups In Vivacity‑MG3Johnson & Johnson highlighted how nipocalimab performs across different points in the gMG journey rather than only in a single, h...
www.ipharmacenter.com
June 29, 2026 at 4:16 PM
#EAN2026 - #Nipocalimab Shows Durable MG‑ADL Gains Across Subgroups In Vivacity‑MG3
www.ipharmacenter.com/post/europea...
#news #media #pharma #pharmaceutical #neurology #europe #healthcare #globalhealth
www.ipharmacenter.com/post/europea...
#news #media #pharma #pharmaceutical #neurology #europe #healthcare #globalhealth
News (from march) with a limited range but big for me. Niopcalimab for moderate to severe Sjogrens got a fast track designation from the FDA. www.jnj.com/media-center...
Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren’s disease, has now receive...
Sjögren’s disease (SjD) is a prevalent, debilitating autoantibody disease with no FDA-approved advanced treatments The Company is actively enrolling patients in the Phase 3 DAFFODIL study This marks t...
www.jnj.com
May 2, 2025 at 3:38 PM
News (from march) with a limited range but big for me. Niopcalimab for moderate to severe Sjogrens got a fast track designation from the FDA. www.jnj.com/media-center...
Carlo Antozzi, MD, discusses results from the phase 3 Vivacity-MG3 study of nipocalimab in antibody positive adults with generalized myasthenia gravis (MG).
checkrare.com/results-from...
#CheckRare #MyastheniaGravis #RareNeurology #RareMusculoskeletal
checkrare.com/results-from...
#CheckRare #MyastheniaGravis #RareNeurology #RareMusculoskeletal
Results From the Phase 3 Vivacity-MG3 Study in Myasthenia Gravis
Carlo Antozzi, MD, discusses results from the phase 3 Vivacity-MG3 study of nipocalimab in antibody positive adults with MG.
checkrare.com
March 3, 2025 at 8:21 PM
Carlo Antozzi, MD, discusses results from the phase 3 Vivacity-MG3 study of nipocalimab in antibody positive adults with generalized myasthenia gravis (MG).
checkrare.com/results-from...
#CheckRare #MyastheniaGravis #RareNeurology #RareMusculoskeletal
checkrare.com/results-from...
#CheckRare #MyastheniaGravis #RareNeurology #RareMusculoskeletal
My top anticipated #ACR24 data
👉 BMS-986353 auto CD19 CAR T in AI
👉 cCAR (CD19 and BCMA CAR T) in SLE/LN
👉 Deucravacitinib (TYK2) in SLE
👉 KYV-101 (auto CD19 CAR T) in LN/SSc
👉 Nipocalimab (anti-FcRn) in SjS
👉 Teclistamab (BCMA x CD3 TCE) in AI
Anything to add @rheumcat.bsky.social? #MedSky
👉 BMS-986353 auto CD19 CAR T in AI
👉 cCAR (CD19 and BCMA CAR T) in SLE/LN
👉 Deucravacitinib (TYK2) in SLE
👉 KYV-101 (auto CD19 CAR T) in LN/SSc
👉 Nipocalimab (anti-FcRn) in SjS
👉 Teclistamab (BCMA x CD3 TCE) in AI
Anything to add @rheumcat.bsky.social? #MedSky
November 14, 2024 at 6:12 AM
My top anticipated #ACR24 data
👉 BMS-986353 auto CD19 CAR T in AI
👉 cCAR (CD19 and BCMA CAR T) in SLE/LN
👉 Deucravacitinib (TYK2) in SLE
👉 KYV-101 (auto CD19 CAR T) in LN/SSc
👉 Nipocalimab (anti-FcRn) in SjS
👉 Teclistamab (BCMA x CD3 TCE) in AI
Anything to add @rheumcat.bsky.social? #MedSky
👉 BMS-986353 auto CD19 CAR T in AI
👉 cCAR (CD19 and BCMA CAR T) in SLE/LN
👉 Deucravacitinib (TYK2) in SLE
👉 KYV-101 (auto CD19 CAR T) in LN/SSc
👉 Nipocalimab (anti-FcRn) in SjS
👉 Teclistamab (BCMA x CD3 TCE) in AI
Anything to add @rheumcat.bsky.social? #MedSky
J&J announced positive topline results from Phase 2b JASMINE study showing the efficacy of of nipocalimab, FcRn blocker that reduces AutoAbs & B cell activity. Study met its 24 wk primary endpoint (SRI-4 response) vs placebo. There were no new safety signals www.jnj.com/media-center...
Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study
The JASMINE study met the primary endpoint and key secondary and exploratory endpoints, including those indicating the potential of nipocalimab for steroid sparing SLE is one of the most prevalent…
www.jnj.com
January 9, 2026 at 12:00 AM
J&J announced positive topline results from Phase 2b JASMINE study showing the efficacy of of nipocalimab, FcRn blocker that reduces AutoAbs & B cell activity. Study met its 24 wk primary endpoint (SRI-4 response) vs placebo. There were no new safety signals www.jnj.com/media-center...
NEWS: J&J's nipocalimab fast-tracked for Sjogren's disease
pharmaphorum.com/news/jjs-nip...
pharmaphorum.com/news/jjs-nip...
J&J's nipocalimab fast-tracked for Sjogren's disease
Johnson & Johnson's FcRn inhibitor nipocalimab has been awarded fast-track status by the FDA as a treatment for Sjogren's disease
pharmaphorum.com
March 19, 2025 at 11:39 AM
NEWS: J&J's nipocalimab fast-tracked for Sjogren's disease
pharmaphorum.com/news/jjs-nip...
pharmaphorum.com/news/jjs-nip...
Nipocalimab (mAb) Phase 3 Clinical Trial is now recruiting for Sjogren's Disease in USA, UK, Japan, and Taiwan
For cities/locations, see the clinical trials link.
www.clinicaltrials.gov/study/NCT067...
For cities/locations, see the clinical trials link.
www.clinicaltrials.gov/study/NCT067...
ClinicalTrials.gov
www.clinicaltrials.gov
March 23, 2025 at 6:47 AM
Nipocalimab (mAb) Phase 3 Clinical Trial is now recruiting for Sjogren's Disease in USA, UK, Japan, and Taiwan
For cities/locations, see the clinical trials link.
www.clinicaltrials.gov/study/NCT067...
For cities/locations, see the clinical trials link.
www.clinicaltrials.gov/study/NCT067...
The U.S. FDA has approved Imaavy (nipocalimab) for the treatment of generalized myasthenia gravis.
checkrare.com/fda-approves...
#CheckRare #FDAApproval #MyastheniaGravis #RareNeurology #RareMusculoskeletal
checkrare.com/fda-approves...
#CheckRare #FDAApproval #MyastheniaGravis #RareNeurology #RareMusculoskeletal
FDA Approves Myasthenia Gravis Treatment Nipocalimab
The U.S. Food and Drug Administration (FDA) has approved Imaavy (nipocalimab) for the treatment of generalized myasthenia gravis (MG).
checkrare.com
May 6, 2025 at 11:09 PM
The U.S. FDA has approved Imaavy (nipocalimab) for the treatment of generalized myasthenia gravis.
checkrare.com/fda-approves...
#CheckRare #FDAApproval #MyastheniaGravis #RareNeurology #RareMusculoskeletal
checkrare.com/fda-approves...
#CheckRare #FDAApproval #MyastheniaGravis #RareNeurology #RareMusculoskeletal
Strasbourg, son centre d'expertise sur les maladies auto-immunes systémiques rares et le nipocalimab
Strasbourg, son centre d'expertise sur les maladies auto-immunes systémiques rares et le nipocalimab
ebx.sh
August 26, 2026 at 3:04 PM
Strasbourg, son centre d'expertise sur les maladies auto-immunes systémiques rares et le nipocalimab
November 18, 2024 at 2:30 PM