DelveInsight
Apr 08, 2025
Amgen’s UPLIZNA Wins First FDA Nod for IgG4-Related Disease; Aldeyra Gets FDA CRL for Reproxalap in Dry Eye; Novartis’ Vanrafia Snags Accelerated FDA OK for IgAN Proteinuria; Biogen’s BIIB080 Earns Fast Track for Alzheimer’s; Epicrispr’s EPI-321 Cleared by FDA for FSHD
Amgen’s UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease Amgen announced that the FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), a rare and chronic immune-mediated inflammatory condition that can affec...
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Apr 02, 2025
Revolutionary Advances and Bright New Horizons in Multiple Myeloma Treatment
Multiple myeloma, a complex blood cancer rooted in the bone marrow, affects 160K people globally each year, with a mortality rate of 106K. According to DelveInsight, nearly 75K new cases were reported across seven major markets in 2023, a figure expected to climb in the coming years. Yet, amid these sobering statis...
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Apr 01, 2025
Sanofi’s Qfitlia Becomes First FDA-Approved Therapy for Hemophilia A or B; FDA Approves AstraZeneca’s IMFINZI as First Perioperative Immunotherapy for Bladder Cancer; Beam Therapeutics’ BEAM-302 for AATD Receives FDA Clearance; AstraZeneca’s CALQUENCE Combo Greenlit in EU for Mantle Cell Lymphoma; Ionis’ WAINZUA Wins EU Approval for Hereditary Transthyretin Amyloidosis
Sanofi’s Qfitlia Becomes First US-Approved Therapy for Hemophilia A or B The FDA has approved Qfitlia (fitusiran), the first antithrombin-lowering therapy for routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A or hemophilia B patients (ages 12+) with or without inhibitors. Approval is bas...
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Mar 25, 2025
Clover’s SCB-1019 RSV Revaccination Study Clears U.S. IND; FDA Approves AMVUTTRA for ATTR-CM CV Risk Reduction; Pembrolizumab Combo Greenlit for HER2+ Gastric/GEJ Cancer; TREMFYA Becomes First IL-23 Inhibitor Approved for Crohn’s; FDA OKs GOZELLIX for Prostate Cancer Imaging
Clover’s RSV Vaccine Candidate SCB-1019 Gains U.S. IND Clearance for Revaccination Study Clover Biopharmaceuticals, Ltd. has received FDA clearance for its Investigational New Drug (IND) application and has initiated a Phase I revaccination clinical trial for SCB-1019, its non-adjuvanted bivalent RSV prefusion-s...
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Mar 18, 2025
FDA Expands SOLIRIS for Pediatric Myasthenia Gravis; vTv’s Cadisegliatin Program Resumes as FDA Lifts Hold; ENCell’s EN001 Wins Orphan Drug Designation for Charcot-Marie-Tooth; FDA Accepts Sydnexis’ NDA for SYD-101 in Pediatric Myopia; Cambium Bio’s Potency Assay Strategy Cleared for Elate Ocular Phase III Trials
MDA Applauds FDA’s Expanded Approval of Soliris for Pediatric Generalized Myasthenia Gravis The Muscular Dystrophy Association (MDA) celebrates the FDA approval of an expanded indication for Alexion/AstraZeneca’s eculizumab (Soliris), now authorized for pediatric patients aged six and older with generalized myas...
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Mar 11, 2025
Neurotech’s ENCELTO Becomes First FDA-Approved Treatment for MacTel Type 2; Plus Therapeutics’ Rhenium Obisbemeda Gets FDA Orphan Status; Novo Nordisk Cuts WEGOVY to $499/Month; Capricor’s Deramiocel Wins FDA Priority Review; Celltrion’s OMLYCLO Becomes First Interchangeable XOLAIR Biosimilar
Neurotech’s ENCELTO Becomes First FDA-Approved Treatment for Macular Telangiectasia Type 2 Neurotech Pharmaceuticals, Inc. has announced that the FDA has approved ENCELTO (revakinagene taroretcel-lwey) for the treatment of Macular Telangiectasia type 2 (MacTel), a progressive neurodegenerative retinal disease th...
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Mar 04, 2025
PRGN-2012 Wins Priority Review for Recurrent Respiratory Papillomatosis; PYX-201 Granted Fast Track for R/M HNSCC; AJA001 IND Cleared for Autism Spectrum Disorder; LAE120 IND Approved for Advanced Solid Tumors; Relacorilant NDA Accepted for Hypercortisolism Treatment
FDA Grants Priority Review to Precigen’s BLA for PRGN-2012 in Recurrent Respiratory Papillomatosis Precigen, Inc. announced that the FDA has accepted its Biologics License Application (BLA) for PRGN-2012 (zopapogene imadenovec†), an investigational AdenoVerse gene therapy for adults with recurrent respiratory pa...
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Feb 26, 2025
Alzheimer’s Treatment: Latest Breakthroughs and Advancements in Therapeutic Development
Alzheimer’s disease remains one of the most complex and devastating neurodegenerative disorders, affecting millions worldwide and placing an immense burden on patients, caregivers, and healthcare systems. Characterized by progressive cognitive decline, memory loss, and functional impairment, Alzheimer’s disease cur...
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Feb 25, 2025
CTEXLI Approved for Cerebrotendinous Xanthomatosis; SIGX1094 Wins Fast Track for Diffuse Gastric Cancer; Bavarian Nordic’s Chikungunya Vaccine Cleared for Ages 12+; UX111 Gene Therapy Gains Priority Review for Sanfilippo Syndrome; SUBLOCADE Label Update Approved
FDA Approves CTEXLI, the First-Ever Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disorder Mirum Pharmaceuticals, Inc. announced that the FDA has approved CTEXLI (chenodiol) tablets as the first and only treatment for cerebrotendinous xanthomatosis (CTX), a rare, progressive, and debilitatin...
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Feb 12, 2025
Exploring the Current Alzheimer’s Disease Drug Development Pipeline
Alzheimer's disease continues to pose a significant challenge to global healthcare systems, with the 7MM reporting approximately 16 million diagnosed prevalent cases in 2023. This rising AD prevalence highlights an urgent need for innovative treatments to mitigate the growing disease burden on both patients and car...
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