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FDA Approved Drug Products Approval List March 2024
30 Mar 2024 10:39 GMT
… ORIG-1 RIFAXIMIN NORWICH PHARMACEUTICALS INC Tentative Approval 03 … 761044 SUPPL-13 USTEKINUMAB JANSSEN BIOTECH Approval 03/ … #090218 SUPPL-28 GLATIRAMER ACETATE SANDOZ Labeling Approval … SUPPL-15 PRALSETINIB BLUEPRINT MEDICINES Labeling Approval 03…
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Are new treatments for multiple sclerosis on the horizon?
27 Mar 2024 18:35 GMT
… treatments for multiple sclerosis?
Currently available medicines include disease-modifying drugs … BTK inhibitor clinical trials
French biopharma Sanofi’ … trial flops in a report by Fierce Biotech. … the FDA with their immunomodulatory drug glatiramer acetate …
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FDA Rejects Regeneron’s Blood Cancer Therapy for Two Forms of Lymphoma
25 Mar 2024 18:15 GMT
… s efficacy or safety, trial design, labeling or manufacturing … of treatment. However, the FDA required that the trials include … European Medicines Agency started a regulatory review of the drug, … FDA rejected Viatris and Mapi Pharma’s formulation of glatiramer …
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Revolutionizing Antiviral Therapeutics: Unveiling Innovative Approaches for Enhanced Drug Efficacy
20 Mar 2024 14:33 GMT
… in either treatment-experienced or treatment-naive individuals … of two FDA-approved medications, sitagliptin (SIT) and glatiramer acetate ( … participated in clinical trials using these colloidal … of molecular pharmaceutics:
Nanoparticle Drug Delivery Systems
…
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FDA Updates for Week of March 11: First CAR-T for CLL/SLL and First NASH Treatment
16 Mar 2024 18:54 GMT
… B-cell lymphoma. Treatments primarily consist of targeted … Mirum Pharmaceuticals, Livmarli was approved by the FDA in … medications. I
FDA Issues CRL for Monthly MS Drug
The FDA … from attacking myelin. Available glatiramer acetate therapies involve injections …
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Positive Phase 1 Study of Monepantel, CRL Given to GA Depot, FDA Rejects Tasimelteon sNDA
16 Mar 2024 12:06 GMT
… glatiramer acetate (GA Depot) solution as a potential treatment … In the trial, treatment with GA … Pharmaceuticals'; supplemental new drug application (sNDA) for tasimelteon (Hetlioz) in the treatment … FDA issued a Complete Response Letter (CRL) stating …
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FDA Approves Single-Dose SelfJect Injector Delivery Device for Inflammatory and Autoimmune Conditions
12 Mar 2024 23:27 GMT
… ; Mallinkckrodt), a treatment indicated for a various … medical professionals managing these challenging conditions."
READ MORE: FDA … Issues Complete Response Letter for Long-Acting Form of Glatiramer … US FDA approval of supplemental new drug application …
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FDA rejects new drug application for intramuscular MS treatment
13 Mar 2024 19:13 GMT
… drug application for GA Depot 40 mg, a long-acting glatiramer … response letter from the FDA regarding the NDA. The … provide an important new treatment advancement for patients with … -controlled, phase 3 clinical trial evaluating safety, efficacy and …
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FDA Rejects Viatris, Mapi’s Long-Acting Multiple Sclerosis Injection
11 Mar 2024 15:36 GMT
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Originally developed by Teva Pharmaceuticals, glatiramer acetate was first approved in … in 1996 for the treatment of relapsing forms of … supported their New Drug Application, which the FDA accepted in … failed two Phase III trials in December 2023, unable …
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FDA Issues Complete Response Letter for Long-Acting Form of Glatiramer Acetate for Relapsing Multiple Sclerosis
11 Mar 2024 13:02 GMT
… to an announcement, the FDA has issued a complete … monthly glatiramer acetate (GA Depot) solution as a potential treatment for … agency originally accepted the new drug application (NDA), which … November 2023. In the trial, treatment with GA Depot led to …