The FDA has accepted the resubmitted BLA for tabelecleucel (tab-cel), intended for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Health policy researcher Geoffrey Joyce argues that only delinking compensation from the list price of a drug will lower drug spending.

In this interview, Sarah Morris, chief product officer of Audere, explains why they chose to focus on women and young girls and how they have tailored their program to reach them.

Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.

The vision research community rallies to protect the National Eye Institute from funding cuts, emphasizing its vital role in preventing blindness and advancing treatments.

Employers increasingly shift health benefit costs to workers in 2026, while prioritizing mental health and innovative affordability strategies.

A scleroderma patient in a Sylvester Comprehensive Cancer Center trial was recently successfully treated with CAR T-cell lymphoma therapy, in what researchers are calling an “immunological reset.”

BioMarin's Roctavian gene therapy shows long-term effectiveness in treating severe hemophilia A, reducing bleeding and improving quality of life for patients.

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results from the IGNYTE trial.

Humana has released details about additional, upcoming organizational improvements to encourage a faster prior authorization process, lessen system waste and increase transparency.

The Vision Center at Children’s Hospital Los Angeles is developing a protocol for a phase 1 clinical trial for the first gene therapy for boys with blue cone monochromacy, which impairs color vision and severely affects visual function.

Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.

This biosimilars market report focuses on rising market complexity and recent activity, including two new approvals and four launches in Q2.

Icotrokinra is a first-in-class targeted oral peptide that blocks interleukin (IL) 23 and its receptor, which plays a key role in the inflammatory response in plaque psoriasis.

Here’s what you missed this week on Managed Healthcare Executive.

Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.

Driven by expensive drugs, hospital stays and growing behavioral health needs, healthcare spending is expected to keep rising—encouraging insurers to tighten oversight and explore new ways to control costs.

Autoimmune diseases, such as vitiligo, celiac disease and rheumatoid arthritis, are not tied to aluminum exposure from vaccines, according to a nationwide cohort study of approximately 1.2 million children done in Denmark.

In early research, OCU410ST, a gene therapy for Stargardt disease, demonstrated slowed lesion growth by 48% at the 12-month follow-up in evaluable treated eyes.

Switching to extended half-life from standard half-life therapies for hemophilia enhances treatment adherence and reduces infusion frequency, despite initial cost increases.

The combination of RPI, a genetically engineered herpes simplex virus type 1, and Opdivo shrank both injected and non-injected tumors by 30%.

H. pylori infection significantly contributes to stomach cancer risk, but effective screening and treatment can prevent millions of cases globally.

A panel of 12 experts in the menopause field reexamined the findings of the 2002 Women’s Health Initiative study that said there were more risks than benefits for menopausal women taking hormone therapy.

Frequent flares in atopic dermatitis predict future disease severity, highlighting the need for improved treatment strategies, as found in a new study published in JAMA Dermatology.