-
Approval of Roche/Genentech’s Gazyvaro Set to Reshape the EU5 Lupus Nephritis Treatment Landscape, According to Spherix Global Insights
11 Dec 2025 14:51 GMT
… biologic anchor in LN treatment. Clinicians report reassessing … share from GSK’s Benlysta. Nearly 30% of Class … into patient journeys and treatment outcomes. About RealTime Dynamix … highlights clinical decision-making, treatment sequencing, and outcomes for …
-
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 …
-
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 …
-
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 …
-
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 …
-
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 …
-
FDA news in pediatrics: June 2025
01 Jul 2025 20:03 GMT
… treatments without medication side effects.
On June 9, 2025, the FDA … phase 3 SMART trials, which demonstrated that … the CLEVER trial, clesrovimab reduced medically attended lower … (KalVista Pharmaceuticals), an investigational oral treatment for hereditary …
-
FDA Approves Benlysta Autoinjector for Pediatric Patients With Active Lupus Nephritis
01 Jul 2025 02:29 GMT
-
FDA Approves Benlysta Autoinjector for Pediatric Lupus Nephritis
27 Jun 2025 16:55 GMT
… the U.S. Food and Drug Administration (FDA) has approved a 200 … aggressive and severe. Having the Benlysta autoinjector provides a much-needed … receive an effective treatment at home, easing their treatment journey.”
Caregivers of …
-
FDA Approves Belimumab Autoinjection for Patients 5 and Older With Active Lupus Nephritis
25 Jun 2025 01:42 GMT
… cure for lupus nephritis, but treatment can include steroids, cyclosporine, … older could only receive the medication through an intravenous formulation … for our free Drug Topics newsletter.
REFERENCES
1. FDA approves Benlysta (belimumab) Autoinjector …