Myasthenia Gravis
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CLINICAL_TRIALS research · 2024-07-31Clinical Trial Update: Predictors and Prognostic Factors of Myasthenia Gravis Outcome
A prospective study sponsored by Assiut University exploring predictors and prognostic factors that influence outcomes in Myasthenia Gravis.…
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FDA approval · 2024-06-21FDA Approved: VYVGART HYTRULO — Supplemental Application (argenx US)
The FDA approved a supplemental application for VYVGART HYTRULO (efgartigimod alfa and hyaluronidase) submitted by argenx US.
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FDA approval · 2024-06-14FDA Approved: RYSTIGGO — Supplemental Application (UCB, Inc.)
FDA approved a supplemental application for RYSTIGGO (rozanolixizumab) from UCB, Inc., supporting an updated indication or labeling.
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CLINICAL_TRIALS research · 2024-06-05Clinical Trial Update: National, Multicentric Registry Study on Neuroimmunological Diseases in China
National multicentric registry in China studying neuroimmunological diseases is currently recruiting, covering conditions such as Multiple S…
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CLINICAL_TRIALS research · 2024-06-04Clinical Trial Update: Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis
This is an observational clinical trial using environmental and wearable sensors to study Myasthenia Gravis and related myasthenic condition…
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CLINICAL_TRIALS trial_result · 2024-06-03Clinical Trial Update: The Impact of Myasthenia Gravis in the Real World
This document reports on a completed clinical trial assessing the real-world impact of Myasthenia Gravis.
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FDA approval · 2024-05-28FDA Approved: BKEMV — Original Application (Amgen Inc)
FDA approved BKEMV (eculizumab-aeeB), a biosimilar to eculizumab, developed by Amgen. The approval covers the same indications as the refere…
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CLINICAL_TRIALS trial_result · 2024-04-08Clinical Trial Update: Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis [Phase 3]
Phase 3 trial of tolebrutinib for generalized myasthenia gravis was terminated, but efficacy and safety results have been posted.
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CLINICAL_TRIALS trial_result · 2023-12-20Clinical Trial Update: A Study of RVT-1401 in Myasthenia Gravis (MG) Patients [Phase 2]
Phase 2 trial of RVT-1401 in Myasthenia Gravis has been completed with results posted in 2023.
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FDA approval · 2023-11-02FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Eugia US LLC)
FDA approved the original application (ANDA 213244) for Neostigmine methylsulfate by Eugia US LLC, authorizing its generic entry and labelin…
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FDA approval · 2023-09-21FDA Approved: PYRIDOSTIGMINE BROMIDE — Original Application (Novadoz Pharmaceuticals LLC)
The FDA approved pyridostigmine bromide as a generic under an Original Application from Novadoz Pharmaceuticals LLC. It is indicated for the…
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CLINICAL_TRIALS trial_result · 2023-07-14Clinical Trial Update: A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness. [Phase 3]
Phase 3 trial update on ARGX-113 in generalized myasthenia gravis reports safety and tolerability findings.
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CLINICAL_TRIALS trial_result · 2023-06-26Clinical Trial Update: Pyridostigmine and Amifampridine for Myasthenia Gravis [Phase 3]
Phase 3 clinical trial update for pyridostigmine and amifampridine in myasthenia gravis is in UNKNOWN status.
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FDA approval · 2023-06-20FDA Approved: VYVGART HYTRULO — Original Application (argenx US)
The FDA approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase, human recombinant) under an Original Application from argenx US. It i…
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CLINICAL_TRIALS trial_result · 2023-06-02Clinical Trial Update: A Study of TAK-079 in People With Generalized Myasthenia Gravis [Phase 2]
Phase 2 clinical trial update for TAK-079 in generalized myasthenia gravis has completed with results posted.
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CLINICAL_TRIALS trial_result · 2023-03-08Clinical Trial Update: Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG Patients [Phase 3]
Phase 3 trial evaluating the efficacy and safety of HBM9161 (HL161) subcutaneous injection in generalized myasthenia gravis has completed.
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CLINICAL_TRIALS trial_result · 2023-03-08Clinical Trial Update: Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis [Phase 3]
Phase 3 trial update on the safety of HBM9161 (HL161) given subcutaneously in generalized myasthenia gravis.
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CLINICAL_TRIALS trial_result · 2023-03-08Clinical Trial Update: A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients [Phase 2]
Phase 2 clinical trial evaluating efficacy, safety, pharmacodynamics and pharmacokinetics of HBM9161 in patients with Myasthenia Gravis has …
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CLINICAL_TRIALS trial_result · 2023-02-21Clinical Trial Update: A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG) [Phase 3]
A Phase 3 pilot trial evaluating subcutaneous immunoglobulin (SCIG) in patients with Myasthenia Gravis exacerbation has completed.
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FDA approval · 2022-11-25FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved an original ANDA for Neostigmine methylsulfate from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals Inc.), a generic versi…
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FDA approval · 2022-11-16FDA Approved: NEOSTIGMINE METHYLSULFATE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental ANDA for Neostigmine methylsulfate by Amneal Pharmaceuticals LLC.
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CLINICAL_TRIALS trial_result · 2022-08-25Clinical Trial Update: A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG) [Phase 3]
Phase 3 open-label study of eculizumab in pediatric patients with refractory generalized myasthenia gravis completed; results posted in 2022…
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FDA approval · 2022-06-08FDA Approved: NEOSTIGMINE METHYLSULFATE — Supplemental Application (Civica, Inc.)
The FDA approved a supplemental application for Neostigmine methylsulfate filed by Civica, Inc. This approval covers the drug under the term…
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FDA approval · 2022-06-08FDA Approved: NEOSTIGMINE — Supplemental Application (Dr.Reddy's Laboratories Inc)
FDA approved Dr. Reddy's Laboratories' supplemental application for neostigmine (generic) under the ANDA program. This action records an app…
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FDA approval · 2022-05-31FDA Approved: NEOSTIGMINE METHYLSULFATE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for Neostigmine Methylsulfate submitted by Par Health USA, LLC.