DelveInsight
Oct 01, 2024
IntraBio’s AQNEURSA Niemann-Pick Disease Approval; FDA Approves Novel Schizophrenia Drug After 35 Years; Selpercatinib Gets FDA Nod for RET-Mutated MTC; DUPIXENT Receives First-Ever COPD Approval; Pfizer Withdraws OXBRYTA for Sickle Cell Disease from Global Market
IntraBio's AQNEURSA Receives Historic FDA Approval for Niemann-Pick Disease Type C Treatment IntraBio Inc. has received approval from the FDA for AQNEURSA (levacetylleucine), marking a significant milestone in the treatment of neurological manifestations of Niemann-Pick disease type C in both adults and pe...
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Sep 17, 2024
Johnson & Johnson’s TREMFYA Approved for Ulcerative Colitis; Roche’s Tecentriq Hybreza Approved as Subcutaneous Anti-PD-(L)1; OCREVUS ZUNOVO Receives Twice-a-Year Multiple Sclerosis Injection Approval; Lilly’s EBGLYSS Greenlit for Moderate-to-Severe Atopic Dermatitis; DUPIXENT Approved for Adolescents with Chronic Rhinosinusitis
TREMFYA Approved for Moderately to Severely Active Ulcerative Colitis Johnson & Johnson announced that the FDA has approved TREMFYA (guselkumab) for treating adults with moderately to severely active ulcerative colitis. TREMFYA is the first fully human, dual-acting monoclonal antibody that blocks IL-23 and b...
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Sep 12, 2024
SpectraWAVE raised $50M; Rockwell Medical signed dialysis deal; Modular Medical got FDA nod for Modd1 pump; iRhythm’s Zio approved in Japan; Autonomix trial showed 83% pain reduction; Insulin Efsitora Alfa improved A1C.
Modular Medical Announced the FDA Clearance for the Modd1 Insulin Pump On September 5, 2024, Modular Medical, Inc., an insulin delivery system technology company, announced that it received the U.S. Food and Drug Administration (FDA) clearance to market and sell its MODD1 pump in the United States. With it...
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Sep 10, 2024
Biogen’s SPINRAZA Phase II/III Trial Results; Travere’s FILSPARI FDA Approval; GSK’s NUCALA Succeeds in COPD Trial; Summit’s NSCLC Win Over KEYTRUDA Raises Caution; FDA Lifts Hold on RZ358 for Congenital Hyperinsulinism
Biogen's Higher SPINRAZA Dose Shows Improved Efficacy in Phase II/III Trial A trial studying a higher dose of Biogen’s spinal muscular atrophy drug SPINRAZA (nusinersen) has met the primary endpoint in a cohort of infants with SMA. The Phase II/III DEVOTE study, which included 145 patients across various ages an...
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Sep 04, 2024
Nonalcoholic Steatohepatitis (NASH): A Growing Epidemic
Obesity and diabetes are a global epidemic contributing to an increasing prevalence of related systemic disorders, including non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). Nonalcoholic Steatohepatitis is a subtype of NAFLD (Nonalcoholic Fatty Liver disease) that is characterized...
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Sep 04, 2024
Meeting the Unmet: Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic Steatohepatitis (NASH) is a severe form of nonalcoholic fatty liver disease (NAFLD), characterized by liver inflammation and damage due to fat accumulation. Unlike simple fatty liver, NASH can progress to serious conditions such as fibrosis, cirrhosis, and liver failure. This chronic liver disease is i...
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Sep 04, 2024
Exploring the Nonalcoholic Steatohepatitis (NASH) Landscape
Nonalcoholic Steatohepatitis (NASH) is a severe form of nonalcoholic fatty liver disease (NAFLD), characterized by liver inflammation and damage due to fat accumulation in the liver. Unlike simple fatty liver, NASH can progress to more serious conditions such as fibrosis, cirrhosis, and even liver failure. This chr...
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Sep 03, 2024
Bayer Phase III NSCLC Trial; D&D Pharmatech Gets FDA Nod for GLP-1R Agonist in Multiple Scletosis; Merck Halts Two KEYTRUDA Trials; Novartis Expands LEQVIO After Phase III Success; Alnylam Reports Strong Phase III Data for Vutrisiran
Bayer Starts Phase III Trial In Non-Small Cell Lung Cancer (NSCLC) Bayer has officially enrolled the first patient in the global Phase III SOHO-02 trial, which will evaluate the efficacy and safety of BAY 2927088 as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with activating HER2 mutat...
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Aug 27, 2024
Merck’s WINREVAIR™ EU Approval; BALVERSA for Urothelial Carcinoma; Novartis and Versant’s Borealis Launched; Moderna’s RSV mRESVIA® EU Approval; FDA Nods RYBREVANT® and LAZCLUZE™ for EGFR-mutated Lung Cancer
Merck’s WINREVAIR Approved by the European Commission for PAH in Adults with Functional Class II-III Merck has secured European Commission (EC) approval for WINREVAIR™ (sotatercept), marking it as the first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH) approved across all 27 EU me...
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Aug 18, 2024
Duchenne Muscular Dystrophy: Advances, Challenges, and the Future of Treatment
"Research is the only hope for families affected by Duchenne muscular dystrophy, and every step forward is a step closer to a cure." Duchenne Muscular Dystrophy (DMD) is a severe form of muscular dystrophy characterized by progressive muscle degeneration and weakness. It is a rare disorder, but it is one of th...
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