The FDA’s accelerated approval of GENGLYCOS™ (pariglasgene brecaparvovec-opnr), also known as DTX401, introduces the first FDA-approved treatment option for glycogen storage disease type Ia (GSDIa).
Read moreMitch Waltman Joins Summit Re's Sales Team
Summit Reinsurance Services, Inc. has named Mitch Waltman to the position of director, business development. Mitch comes to Summit Re with a deep well of understanding of the insurance and reinsurance business. His extensive professional experience has included time in the insurance premium-finance, employee benefits, specialty accident and health (A&H), and reinsurance industry sectors. Most recently, he was responsible for the strategic development and management of program partnerships across NGL Insurance Company’s specialty A&H and employee benefits books of business.
Mitch started his career in 1998 working for a subsidiary of ING Americas. As his career progressed, he spent close to a decade handling senior level sales, business development, and underwriting roles for the reinsurance operation of ING Americas, which today is part of RGA.
In his new role with Summit Re, Waltman will cultivate and sustain key relationships focusing on HMO reinsurance and provider excess loss products.
Hospital Contracting: Negotiated Base Rates
Hospital contracting is a critical element for health plans because it dictates the plan's financial viability, price predictability, and market competitiveness.
Read moreCell and Gene Therapy Decisions Due Soon
In the next six months, the FDA expects to issue decisions on three novel therapies.
Read moreNew Gene Therapy Approved for Genetic Hearing Loss
On April 23, 2026, the US Food and Drug Administration approved gene therapy Otarmeni (lunsotogene parvec-cwha) for the treatment of genetic hearing loss.
Read moreClinical Trial Evaluating Ryoncil in Duchenne Muscular Dystrophy (DMD)
According to Mesoblast’s press release on April 7, 2026, “This study represents an important step forward in potentially addressing the inflammatory component of DMD, a major driver of disease progression.”
Read moreSpinal Muscular Atrophy Treatment after Zolgensma
A new phase 1b study by Biogen is now evaluating the drug salanersen in patients with SMA who have already received the gene therapy Zolgensma.
Read moreRyoncil Update
On December 18, 2024, the FDA approved Ryoncil (Remestemcel-L-rknd) as the first and only off-the-shelf allogeneic bone marrow-derived mesenchymal stromal cell therapy for children who are two months old to adolescents with steroid-refractory acute graft-versus-host disease (SR-aGVHD).
Read moreMetabolic Health
Metabolic health has been a hot topic for the last couple of years, and that trend looks to continue in 2026.
Read moreCell & Gene Therapy Approval Updates
Read 2025’s final cell and gene therapy updates.
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