Myasthenia Gravis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-05-10FDA Approved: NEOSTIGMINE METHYLSULFATE — Supplemental Application (BE Pharmaceuticals Inc.)
The FDA approved a supplemental application for NEOSTIGMINE METHYLSULFATE from BE Pharmaceuticals Inc., updating the approved product.
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FDA approval · 2022-05-05FDA Approved: NEOSTIGMINE METHYLSULFATE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for neostigmine methylsulfate from Amneal Pharmaceuticals LLC.
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CLINICAL_TRIALS trial_result · 2022-05-02Clinical Trial Update: Efficacy and Safety of Low-dose Rituximab in the Treatment of Refractory Myasthenia Gravis [Phase 3]
Phase 3 trial evaluating low-dose rituximab for efficacy and safety in refractory myasthenia gravis.
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FDA approval · 2022-04-19FDA Approved: PYRIDOSTIGMINE BROMIDE — Original Application (Acella Pharmaceuticals, LLC)
FDA approved the original application for pyridostigmine bromide as a generic product developed by Acella Pharmaceuticals, LLC.
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CLINICAL_TRIALS trial_result · 2022-04-14Clinical Trial Update: The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy [Phase 3]
Phase 3 trial assessing lef lunomide or azathioprine therapy in myasthenia gravis patients after thymectomy; completed study.
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FDA approval · 2021-12-17FDA Approved: VYVGART — Original Application (argenx US)
The FDA approved VYVGART (efgartigimod alfa) in its original application for the treatment of generalized myasthenia gravis.
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FDA approval · 2021-10-01FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Indoco Remedies Limited)
FDA approved the original application for NEOSTIGMINE METHYLSULFATE from Indoco Remedies Limited (ANDA210652). The approval supports its use…
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CLINICAL_TRIALS trial_result · 2021-09-16Clinical Trial Update: Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis [Phase 2]
Phase 2 clinical trial evaluating the efficacy of apraclonidine eye drops for ptosis in myasthenia gravis, completed.
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CLINICAL_TRIALS trial_result · 2021-08-03Clinical Trial Update: Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis [Phase 2]
Phase 2 clinical trial assessing safety, tolerability, and efficacy of UCB7665 in adults with moderate to severe Myasthenia Gravis has compl…
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FDA approval · 2021-04-20FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Somerset Therapeutics, LLC)
The FDA approved a generic version of neostigmine methylsulfate through an original ANDA by Somerset Therapeutics, LLC. It is indicated for …
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FDA approval · 2021-04-05FDA Approved: REGONOL — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for REGONOL (pyridostigmine bromide) filed by Sandoz Inc.
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FDA approval · 2021-04-05FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Meitheal Pharmaceuticals Inc.)
The FDA approved a generic version of neostigmine methylsulfate from Meitheal Pharmaceuticals Inc. for its approved uses in treating myasthe…
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FDA approval · 2021-02-04FDA Approved: NEOSTIGMINE METHYLSULFATE — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for Neostigmine methylsulfate submitted by Fresenius Kabi USA, LLC. The approval updates the product…
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FDA approval · 2021-01-19FDA Approved: BLOXIVERZ — Supplemental Application (Exela Pharma Sciences, LLC)
FDA approved a supplemental application for BLOXIVERZ (neostigmine methylsulfate) submitted by Exela Pharma Sciences, LLC.
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CLINICAL_TRIALS trial_result · 2021-01-08Clinical Trial Update: A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness [Phase 2]
Phase 2 study evaluating the safety, efficacy, and pharmacokinetics of ARGX-113 in patients with generalized Myasthenia Gravis. The study ha…
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CLINICAL_TRIALS trial_result · 2020-04-24Clinical Trial Update: A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations [Phase 3]
Phase 3 clinical trial assessing intravenous immunoglobulin in patients with myasthenia gravis exacerbations has completed with results post…
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CLINICAL_TRIALS trial_result · 2020-04-06Clinical Trial Update: Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia Gravis [Phase 2, Phase 3]
A clinical trial update evaluating a beta-agonist as adjuvant therapy in Myasthenia Gravis across Phase 2 and Phase 3.
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CLINICAL_TRIALS trial_result · 2020-02-26Clinical Trial Update: Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis [Phase 2]
Phase 2 trial evaluating intravenous immunoglobulin G (IGIV-C) for efficacy and safety in corticosteroid-dependent generalized myasthenia gr…
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FDA approval · 2020-01-10FDA Approved: PYRIDOSTIGMINE BROMIDE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approves the original application for pyridostigmine bromide by Amneal Pharmaceuticals NY LLC.
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FDA approval · 2020-01-09FDA Approved: PRYIDOSTIGMINE BROMIDE — Original Application (Apnar Pharma LP)
FDA approved an original application for pyridostigmine bromide from Apnar Pharma LP, establishing a generic version of the drug. The approv…
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CLINICAL_TRIALS trial_result · 2019-12-13Clinical Trial Update: Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis [Phase 2]
Open-label Phase 2 trial evaluating subcutaneous immunoglobulin in patients with Myasthenia Gravis has completed with results posted in 2019…
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FDA approval · 2019-10-29FDA Approved: PYRIDOSTIGMINE BROMIDE — Supplemental Application (Oceanside Pharmaceuticals)
FDA approved a supplemental application for pyridostigmine bromide submitted by Oceanside Pharmaceuticals.
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FDA approval · 2019-10-16FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Gland Pharma Limited)
FDA approved NEOSTIGMINE METHYLSULFATE from Gland Pharma Limited under an original application.
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FDA approval · 2019-05-13FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (BE Pharmaceuticals Inc.)
FDA approved the original application for Neostigmine methylsulfate from BE Pharmaceuticals Inc., authorizing a generic version of this drug…
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FDA approval · 2019-03-08FDA Approved: PYRIDOSTIGMINE — Original Application (Novitium Pharma LLC)
FDA approved pyridostigmine bromide oral from Novitium Pharma LLC under an Original Application (ANDA 211694).