The AJMC® Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.
FDA Greenlights Dupilumab for Chronic Spontaneous Urticaria, Marking First Approval in a Decade
April 18th 2025Marking the first approval in over a decade for this challenging condition, the FDA has approved dupilumab (Dupixent) to treat chronic spontaneous urticaria in patients 12 years and older whose hives and itching remain uncontrolled by antihistamines.
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Newly Approved Triplet Regimen Boosts Survival in R/R LBCL: Craig Portell, MD
April 11th 2025ECHELON-3 (NCT04404283) principal investigator Craig A. Portell, MD, speaks to the significance of this triplet approval from February as an alternative to more complex and time-consuming regimens in the setting of relapsed/refractory large B-cell lymphoma (R/R LBCL).
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Insights Into Iptacopan in C3 Glomerulopathy: Carla Nester, MD, MSA, FASN
April 9th 2025Carla Nester, MD, MSA, FASN, is coinvestigator for the ongoing APPEAR-C3G trial (NCT04817618), data from which were used to support the FDA’s recent approval of iptacopan (Fabhalta; Novartis) in complement 3 glomerulopathy (C3G).
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FDA Approves Cabozantinib for Advanced Pancreatic Neuroendocrine Tumors
March 26th 2025With strong progression-free survival benefits demonstrated in the CABINET trial and updates to National Comprehensive Cancer Network guidelines, this approval reinforces cabozantinib’s role in improving outcomes for patients facing these challenging cancers.
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How Revakinagene Taroretcel Can Benefit Patients With MacTel: Dr Charles Wykoff
March 26th 2025The approval of revakinagene taroretcel (Encelto; Neurotech) addresses a significant unmet need for patients with macular telangiectasia type 2 (MacTel), clinical investigator Charles C. Wykoff, MD, PhD, Retinal Consultants of Texas, said.
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Revakinagene Taroretcel Approval Addresses Unmet Need in MacTel
March 24th 2025Charles C. Wykoff, MD, PhD, Retinal Consultants of Texas, discusses data supporting the FDA approval of revakinagene taroretcel-lwey (Encelto; Neurotech Pharmaceuticals), the first and only therapy indicated for the treatment of macular telangiectasia type 2 (MacTel).
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Second CRL for Rivoceranib/Camrelizumab for Unresectable HCC
March 21st 2025Despite resubmitting after an initial complete response letter (CRL) due to manufacturing issues, the combination therapy received a second CRL as a frontline therapy for unresectable hepatocellular carcinoma (HCC).
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How Mirdametinib Improves QOL for People With NF1-Associated Plexiform Neurofibromas
March 18th 2025Christopher L. Moertel, MD, University of Minnesota, discusses the trial data that helped get mirdametinib approved and what providers can do to keep measuring quality of life (QOL) improvements.
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