Mumbai, India – Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Amifampridine Tablets, 10 mg. This product would be manufactured at Lupin’s Goa facility in India. Amifampridine...
treatment News
LUPKYNIS Data Presented at LUPUS 2025, the 16th International Congress on SLE, May 21-24 ROCKVILLE, Md. & EDMONTON, Alberta — Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced that a post-hoc analysis of the 52-week, Phase 3 AURORA 1 study showed that lupus nephritis (LN) patients who received...
Chicago, Illinois – On March 27, 2024, Ann & Robert H. Lurie Children’s Hospital of Chicago treated its first patient with ELEVIDYS (delandistrogene moxeparvovec-rokl), the first gene therapy for Duchenne muscular dystrophy – a rare, genetic disease characterized by progressive muscle damage and weakness. Lurie Children’s is the first in...
LYL314 demonstrated robust clinical responses, with an 88% overall response rate and a 72% complete response rate in patients treated in the third- or later-line setting (N = 25) 71% of patients with complete response remained in complete response at ≥ 6 months Manageable safety profile appropriate for outpatient administration...
SOUTH SAN FRANCISCO, Calif. — Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced new clinical and translational data from the ongoing clinical trial of rondecabtagene autoleucel (ronde-cel, also known as LYL314) in patients...
Lyme disease is emerging in Canada, and is expected to increase with climate change, but effective, enhanced surveillance and clinician awareness will be key to minimizing the impact of the disease, write researchers in a review in CMAJ (Canadian Medical Association Journal) http://www.cmaj.ca/press/pg1221.pdf (www.cmaj.ca). Lyme disease is transmitted by ticks...
WATERTOWN, Mass. — Lyndra Therapeutics®, a clinical-stage biopharmaceutical company, today announced positive data from the STARLYNG-1 (LYN-005-C-301) study, comparing the pharmacokinetic (PK) profile of oral weekly risperidone (LYN-005) with immediate-release Risperdal administered daily to adults living with schizophrenia and schizoaffective disorder. The STARLYNG-1 study is designed to bridge to the...
TARRYTOWN, N.Y. — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome...
Lysogene (Paris:LYS) (FR0013233475 – LYS), a gene therapy platform Company targeting central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its LYS-GM101 program, which is being studied in the recently initiated global adaptative-design clinical trial for the treatment...
Lysogene (Paris:LYS) (FR0013233475 – LYS), a phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, today announced dosing of the first patient, at Royal Manchester Children’s Hospital, part of Manchester University NHS Foundation Trust, in the global adaptative-design clinical trial with LYS-GM101 (NCT04273269), a gene therapy for...