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First Look at Roche/Genentech’s Gazyva Shows Strong Early Enthusiasm in Lupus Nephritis Launch, According to Spherix Global Insights
19 Nov 2025 20:19 GMT
… by Benlysta (belimumab, GlaxoSmithKline) and Lupkynis (voclosporin, Aurinia Pharmaceuticals) at … sizeable candidate pool for treatment. Projected utilization reinforces Gazyva … within an increasingly dynamic LN treatment landscape. About Launch Dynamix …
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FDA Approval for Roche Cancer Drug Brings a New Biologic Option to Lupus Nephritis
20 Oct 2025 22:26 GMT
… immunosuppressants and anti-inflammatory drugs. Results showed that nearly … in cancer clinical trials included infusion-related reactions … cell survival. Benlysta’s 2011 FDA approval in systemic … week, a European Medicines Agency committee recommended approval …
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Roche's aging oncology blockbuster Gazyva snares FDA nod to move into lupus nephritis
21 Oct 2025 00:23 GMT
… long-approved blood cancer medicine Gazyva.
Early Monday, … it stands, the lupus treatment market—across several distinct … by GSK’s biologic Benlysta. The drug, which falls into … FDA nod for its drug Saphnelo to treat moderate to severe SLE.
Doctors …
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As Roche/Genentech’s Obinutuzumab (Gazyva) Nears FDA Decision, Spherix Global Insights White Paper Reveals Keys to Successful Lupus Product Launches
02 Oct 2025 13:11 GMT
… , MD, Professor of Medicine at Johns Hopkins University … analysis of 15 drug launches between 2020 … treatment landscape continues to expand rapidly. The approvals for Benlysta … FDA and EMA decisions in 2025 following positive Phase III REGENCY trial …
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Indian pharma cos to benefit as drugs worth $236 billion expected to go off-patent in next five years
30 Sep 2025 04:39 GMT
… biosimilars. With 750+ US FDA-approved plants, India is … steep as they get. Medicines worth $236 billion are … Genentech) - HER2+ Breast Cancer, Benlysta (GSK) – Lupus, Elelyso (Pfizer … of generic drugs and especially benefit Indian pharmaceutical companies that …
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Global Benlysta Market Forecast To Reach $3.6 Billion By 2029 With 11.2% Annual Growth
28 Jul 2025 12:53 GMT
… in immunology, innovative drug delivery systems, collaborations … on medical goods and services, including hospital care, pharmaceuticals, … increased investment in treatments for chronic autoimmune … 47;report/benlysta-global-market-report
What …
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Pledging ‘Radical Transparency,’ FDA Reveals Drug Rejection Letters — With Limits
13 Jul 2025 18:50 GMT
… GSK drug at home. Intravenously infused Benlysta was … vaccine as mNEXSPIKE. In the key clinical trial … FDA approved KalVista Pharmaceuticals’ Ekterly, making the pill the first oral on-demand treatment … drug that the biotech had developed as a treatment for …
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Treatment pipeline for cutaneous lupus may ‘offer hope very soon’
18 Jul 2025 16:12 GMT
… phase 3 trial for the drug in CLE is … topical and oral medications. These treatments are often not … stimulator (BLyS) belimumab (Benlysta, GlaxoSmithKline) to anifrolumab … , Nektar, Nuvig Pharmaceuticals, Pfizer, Regeneron, Rome Pharmaceuticals, Sanofi, Takeda …
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Key FDA approvals in pediatric health: First half of 2025
05 Jul 2025 13:34 GMT
… vaccination rates remain low.
The FDA approved epinephrine nasal spray (neffy; ARS Pharmaceuticals … 3 trials, the treatment significantly … trial, clesrovimab reduced medically … FDA approved a 200 mg/mL autoinjector formulation of belimumab (Benlysta …
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FDA News Recap: June 2025
02 Jul 2025 15:05 GMT
… Drug GMRx2 (WIDAPLIK) for Hypertension Treatment
On June 9, 2025, George Medicines announced FDA … phase 3 trials and the VERONICA … 2025, Amneal Pharmaceuticals announced FDA approval of prednisolone … patients.
FDA Approves Belimumab (Benlysta) Autoinjector for …
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