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The FDA letter requested that a technical information update be included in the Chemistry Manufacturing and Controls (CMC) module of the sNDA.

Yael Bensoussan, M.D., director of the University of South Florida Health Voice Center, discusses menopause-related voice changes and how artificial intelligence is being used to address them.

Carbapenemase-producing Enterobacterales (CRE) surge in the U.S., with New Delhi metallo-β-lactamase (NDM) becoming a major public health threat.

The complete response letter was issued by the FDA during a routine inspection of a third-party fill-finish facility, not because of an issue with apitegromab.

Data quality issues and increased rates of claim denials provide opportunities for artificial intelligence to make improvements, according to a recent survey by Experian Health.

Employers adapt healthcare strategies amid rising costs, focusing on specialty drugs and chronic conditions to enhance employee wellbeing and control expenses.

Brian K. Lee, Ph.D., of Drexel University Dornsife School of Public Health, says that despite the fact that some studies suggest there is link between acetaminophen use during pregnancy and neurodevelopmental disorders, there is a lack of evidence to support that conclusion.

Merck's Keytruda Qlex offers a groundbreaking subcutaneous cancer treatment, enhancing patient convenience with faster administration and broader access to immunotherapy.

Tremfya is now the first and only fully subcutaneous IL-23 inhibitor approved to treat both ulcerative colitis and Crohn’s disease.

Opzelura gains FDA approval as the first topical JAK inhibitor for children with atopic dermatitis, offering a steroid-free treatment option.

On the second day of its meeting, the Advisory Committee on Immunization Practices (ACIP) postponed a decision on giving hepatitis B vaccines at birth and revoted against coverage of the combined MMRV vaccine under the Vaccines for Children program.

RxBenefits is aiming to fill gaps in the PBM market with a new option for self-funded employers and brokers, called Illuminate Rx.

This spray formulation of bumetanide demonstrated a 33% faster absorption rate than oral bumetanide, according to clinical trial data.

The Advisory Committee on Immunization Practices pulled back its recommendation concerning a shot that combines the measles, mumps and rubella vaccine with one for varicella. A vote on the hepatitis B vaccine at birth was postponed until tomorrow.

Nearly half of women experience hormone-driven vocal changes during menopause, which may alter voice quality and affect those in voice-reliant careers, a new review finds.

Former CDC director Susan Monarez, Ph.D., testified at today’s Senate hearing that HHS Secretary Robert F. Kennedy Jr. directed her to fire scientists for refusing to rubber-stamp vaccine changes.

RxBenefits has released Illuminate Rx, a new PBM aiming to fill gaps in the current PBM market, according to Robert Gamble, CEO of RxBenefits.

Advances in HIV medication, its window of detection and its transmission risk within the last decade have led to an updated version of the HIV exposure protocol for healthcare personnel.

Elevated levels of the gut hormone GLP-1 and its receptor may worsen brain inflammation and trigger severe symptoms in patients with neuromyelitis optica spectrum disorder (NMOSD), suggesting GLP-1 drugs could pose risks for this rare autoimmune disease.

Results show that GLP-1s may address rheumatoid arthritis (RA) symptoms, independent of established weight loss and cardiac benefits, by reducing the systemic, chronic inflammation associated with RA.

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

Illuminate Rx is the country’s first pharmacist-designed pharmacy benefits optimizer (PBO), offering transparent, clinically driven PBM options for brokers and self-funded employers, with a focus on data clarity, flexible formulary design and specialty pharmacy partnerships, according to Robert Gamble, CEO of RxBenefits.

Diagnosed with triple-negative breast cancer at age 36 and now in remission, Deanna Gerber, M.D., gynecologic oncologist at Weill Cornell Medicine and NewYork-Presbyterian Hospital, says her experience has made her a better physician and advocate for her patients.

A decline in PrEP coverage could reverse HIV prevention gains, causing tens of thousands of preventable infections and billions in added healthcare costs, a new JAMA Network Open study finds.

The new JAMA + Women’s Health multimedia channel focuses on all aspects of women’s health, not just topics like menopause or ovarian cancer, presenting content from across JAMA and JAMA Network in one place.

Provider-sponsored health plans thrive in the evolving ACA market, offering trusted, community-based coverage and efficient care coordination as major insurers exit.

Use of transparent PBMs has surged as employer reliance on the Big Three declines, highlighting shifting strategies to address escalating healthcare costs, the Pulse of the Purchaser 2025 survey finds.

Ongoing research is needed to further explore the best methods for anal cancer detection in people living with HIV, according to a recent review.