Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

The US Food and Drug Administration (FDA) has approved GSK’s leucovorin calcium (Wellcovorin) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1), making it the first treatment for the rare genetic condition of cerebral folate deficiency.

As described in a March 10, 2026, release from the Agency, the approval was based on a systematic review of the published literature on the topic, including published case reports with patient-level information, as well as mechanistic data.

"Today's approval represents a significant milestone for patients living with cerebral folate transport deficiency due to the FOLR1 variant, a rare genetic condition that has had no FDA-approved treatment options until today,” FDA Commissioner Marty Makary, MD, MPH, said in a statement. “This action may benefit some individuals with FOLR1- related cerebral folate transport deficiency who have developmental delays with autistic features.”

In the US, leucovorin is indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. GSK marketed leucovorin under the brand name Wellcovorin from 1983 to 1997, and it is now available in the US as a generic drug.

The FDA collaborated with GSK on a process to update the labeling to include the essential scientific information needed for the safe and effective use of the drug for adults and pediatric patients with CFD-FOLR1, a neurological condition that affects folate transport into the brain.

GSK announced the submission of a supplemental New Drug Application (sNDA) for leucovorin to update the label to include an indication for the treatment of CFD on September 22, 2025. The FDA requested GSK take this action as part of the Agency’s initiative to investigate opportunities to repurpose older medications for the treatment of chronic diseases.

As described by the FDA, possible side effects associated with leucovorin include pruritus, rash, urticaria, dyspnea, rigors, and impaired thermoregulation.

"The approval of leucovorin for FOLR1-related cerebral folate transport deficiency (CFD- FOLR1) demonstrates the FDA’s commitment to rapidly identifying effective treatments for ultra rare diseases while maintaining the same evidentiary standards for approval,” said Tracy Beth Hoeg, MD, PhD, Acting Director of the FDA’s Center for Drug Evaluation and Research. “It also provides a good example of how observational or ‘real world’ evidence can lead to an FDA approval when the product is shown to provide clear clinical benefit compared with what is seen with the natural history of the disease.”

US Food and Drug Administration. FDA Approves First Treatment for Patients with Cerebral Folate Transport Deficiency. March 10, 2026. Accessed March 10, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-cerebral-folate-transport-deficiency

GSK. GSK to submit label update for Wellcovorin (leucovorin) at US FDA’s request. September 22, 2025. Accessed March 10, 2026. 

https://www.gsk.com/en-gb/media/press-releases/gsk-to-submit-label-update-for-wellcovorin-leucovorin-at-us-fda-s-request/

Articles

FDA approval granted for oral leucovorin calcium (Wellcovorin) to treat cerebral folate deficiency due to confirmed FOLR1 (folate receptor 1) variants in adult and pediatric patients, marking the first FDA-approved therapy for this ultra-rare cerebral folate transport disorder. The decision relied on a systematic literature review of case reports with patient-level outcomes plus mechanistic evidence, reflecting a repurposing pathway for an older drug long used as methotrexate rescue. Labeling was updated in collaboration with GSK, with safety considerations including hypersensitivity-type reactions and thermoregulation impairment.

The approval comes after the FDA requested GSK submit an sNDA for leucovorin for the treatment of CFD-FOLR1.

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FDA Approves Leucovorin Calcium (Wellcovorin) Tablets as First Cerebral Folate Deficiency Treatment

Nicole Negbenebor, MD, is a clinical assistant professor of dermatology and the director of the Skin of Color Clinic for the University of Iowa, as well as a Skin of Color Society (SOCS) member.

Skin of Color Savvy: The Art and Science of Treating Patients of Color

Skin of Color Savvy: Challenges and Successes in a Dermatologist’s Career, With Nicole Negbenebor, MD

 leaders, Nicole Negbenebor, MD, clinical assistant professor of dermatology and director of the Skin of Color Clinic at the University of Iowa, discusses her professional journey in 

, highlighting her clinical interests, research advocacy, and commitment to improving care for diverse patient populations.

Negbenebor reflects on the factors drawing her to dermatology back during medical school, citing the specialty’s breadth, diagnostic complexity, and ability to reveal systemic disease through cutaneous findings. She notes that dermatology’s combination of medical management, surgery, pathology, and patient education allows physicians to pursue varied interests while maintaining a strong investigative component. This multidimensional nature of the specialty continues to shape her clinical and research pursuits.

A significant portion of Negbenebor’s work centers on her leadership of the Skin of Color Clinic at the University of Iowa, originally established by a mentor. In this role, she treats a wide spectrum of conditions affecting patients with diverse skin types, including vitiligo, hidradenitis suppurativa (HS), acne keloidalis nuchae, scarring alopecias, and postinflammatory hyperpigmentation.

The clinic also addresses cosmetic dermatology concerns and provides education to dermatology residents rotating through the program. Negbenebor emphasizes the importance of culturally informed care, noting that treatment strategies must often account for hair-care practices, product use, and other cultural considerations not extensively addressed in traditional dermatology training.

Throughout the discussion, she highlights ongoing improvements in awareness of skin of color dermatology but describes some patients as still feeling unheard in clinical settings. Creating spaces where patients feel comfortable discussing concerns, including hair care practices or culturally specific skincare routines, can improve trust and treatment outcomes. Integrating such knowledge into dermatologic care, she adds, is essential to delivering effective and patient-centered management.

Negbenebor also shares examples from her clinical practice illustrating the complexity of dermatologic care. In one case, she describes treating a patient with dermatofibrosarcoma protuberans requiring Mohs surgery, multidisciplinary collaboration, and coordination of social support services, including interpretation and childcare. Experiences such as these underscore the importance of teamwork across specialties to optimize patient outcomes.

Beyond clinical practice, Negbenebor highlights writing and research as key avenues for advocacy. She describes academic writing as a way to document patient experiences, address barriers such as insurance restrictions for biologic therapies, and contribute to broader systemic improvements in care.

Reflecting on her experiences with SOCS, Negbenebor credits the organization’s mentorship programs and educational resources with fostering community and advancing expertise in dermatologic care for patients with skin of color. She concludes by encouraging trainees to seek mentorship, remain persistent in pursuing dermatology, and maintain a strong sense of purpose in caring for patients whose dermatologic conditions significantly affect quality of life.

To learn more about SOCS’s programs and initiatives, visit 

Editor’s note: This summary was edited with the help of AI tools.

Podcasts

This March episode highlights one SOCS member’s journey in dermatology, covering clinical and research passions as well as lessons learned along the way.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Videos

Hosted by Skin of Color Society and produced by HCPLive, 

 delves into the latest research, clinical insights, and culturally intelligent care practices in dermatology with leading experts. 

Whether it’s groundbreaking research, practice-changing insights, or highlights from the SOCS community, this twice-monthly program provides dermatologists and care providers with expert perspectives on treating patients with skin of color.

The expert faculty explore how clinicians approach rectal bleeding and surveillance decisions in colorectal cancer screening.

Colorectal Cancer Screening and Surveillance Decisions

In this episode, ‘Colorectal Cancer Screening and Surveillance Decisions’, the expert faculty explore how clinicians approach rectal bleeding and surveillance decisions in colorectal cancer screening. The discussion highlights rectal bleeding as a key presenting symptom in early-onset colorectal cancer, particularly among younger patients, and examines when colonoscopy is warranted even in the presence of suspected benign causes such as hemorrhoids. Faculty emphasize the importance of follow-up and individualized clinical judgment, especially when recent screening has been performed. The conversation also addresses post-polypectomy management, clarifying differences between hyperplastic polyps and adenomas and how these findings influence future screening strategies. Ultimately, the speakers reinforce that the most effective screening approach is one that aligns with risk profile and ensures patient adherence.

The next episode in this series, ‘Shared Decision-Making in Colorectal Cancer Screening,’ features the panelists highlighting the challenges of engaging patients in colorectal cancer screening and emphasizes the importance of pragmatic, shared decision-making conversations. The faculty discuss how presenting the risks and benefits of colonoscopy and stool-based options can improve patient buy-in and follow-through, while reinforcing the impact of early detection on mortality and quality of life.

Video Series

 In this episode title, ‘Shifting Epidemiology and Risk Factors in Colorectal Cancer,’ the moderator introduces the evolving landscape of colorectal cancer screening and highlights the growing importance of early detection.

Shifting Epidemiology and Risk Factors in Colorectal Cancer 

Welcome back to another HCP Live Peers and Perspectives series. In this episode title, ‘Shifting Epidemiology and Risk Factors in Colorectal Cancer,’ the moderator introduces the evolving landscape of colorectal cancer screening and highlights the growing importance of early detection. The faculty review current epidemiologic trends, noting declining incidence in adults over 50 alongside a concerning rise in cases among individuals aged 40 to 49. They discuss potential contributing factors, including obesity, sedentary lifestyle, dietary habits, and the possibility of a birth cohort effect. The conversation also underscores disparities in incidence and mortality among certain racial and ethnic populations, emphasizing the role of access to care and social determinants of health. Finally, the expert faculty highlight the importance of family history assessment and risk stratification in guiding appropriate screening strategies in clinical practice.

In the next episode, ‘Colorectal Cancer Screening and Surveillance Decisions,’ expert faculty emphasize that rectal bleeding in younger patients warrants a low threshold for colonoscopy, while prior polyp type (eg, hyperplastic, adenomatous) guides whether continued colonoscopy surveillance or noninvasive screening is appropriate.

 In this episode titled, ‘Shifting Epidemiology and Risk Factors in Colorectal Cancer,’ the moderator introduces the evolving landscape of colorectal cancer screening and highlights the growing importance of early detection.

OUtMATCH: Omalizumab and OIT Similarly Enable Allergenic Food Consumption, With Robert Wood, MD

The question driving food allergy research has shifted — from whether patients can be protected against accidental exposures to whether they can actually eat the foods they've spent their lives avoiding. Stage 3 data from the landmark OUtMATCH trial presented at the 

American Academy of Allergy, Asthma & Immunology (AAAAI)

 2026 Annual Meeting held in Philadelphia, Pennsylvania, from February 27 to March 2, suggest the answer, for the majority of patients, is yes — and that both available treatments get them there comparably.

To discuss the findings, we spoke with Robert A. Wood, MD, Chief of the Eudowood Division of Pediatric Allergy and Immunology at Johns Hopkins Children's Center and Professor of Pediatrics at the Johns Hopkins University School of Medicine in Baltimore, and an investigator of OUtMATCH, the multi-stage trial that led to FDA approval of omalizumab for food allergy in 2024.

 Stage 3 addressed the most clinically meaningful question yet: after approximately 52 weeks of either multi-food OIT (mOIT) or omalizumab, could patients successfully introduce and sustain dietary consumption (DC) of their allergenic foods? Of 81 eligible participants, 80 qualified for DC plans following mOIT (n = 29) or omalizumab (n = 51), covering 83 and 139 individual allergen DC plans, respectively. Success was defined as consuming a median of ≥300 mg/day of allergenic food at both 3 and 6 months by daily diary, with additional study team evaluations conducted across all 12 months.

By daily diary, DC plan success rates across all foods showed no significant differences between groups at 3 months (post-mOIT 77% vs. post-omalizumab 66%; 

 = .77). Peanut-specific outcomes mirrored this pattern: post-mOIT 77% and 65% at 3 and 6 months versus post-omalizumab 67% and 60% (

.80, respectively). Study team evaluations likewise showed no group differences at 3, 6, 9, or 12 months across all foods (post-mOIT: 90%, 82%, 75%, 67%; post-omalizumab: 91%, 82%, 69%, 63%; 

 range = 0.44–1.00), with comparable individual allergen outcomes (

Safety profiles were similar among the 52 participants who maintained DC plans for all three foods across 12 months (n = 22 post-mOIT; n = 30 post-omalizumab), with any adverse event reported in 86% (19/22) post-mOIT and 93% (28/30) post-omalizumab. Two serious adverse events occurred during the open feeding transition from mOIT to DC, and 1 case of eosinophilic esophagitis developed during DC post-omalizumab. The tolerability gap between the 2 treatments, however, loomed large in context: roughly half of mOIT patients in Stage 2 could not tolerate the regimen well enough to advance to Stage 3 at all — making omalizumab the more accessible path for a substantial portion of patients. As Wood noted, treatment selection ultimately comes down to the individual: "a very few, let's say teenagers with peanut allergy, are asking to eat peanut — most everyone, if they could, would say, 'Can I eat pizza?' It gets individualized in our clinic for every patient now."

Wood’s disclosures include Aimmune, ALK, DBV Technologies, FARE, Genentech, NIAID, Novartis, Regeneron, Siolta, and Aravax.

1. Chinthrajah RS, Lanser B, Leung D, et al. Evaluation of dietary consumption feasibility following treatment with multi-food oral immunotherapy or omalizumab in OUtMATCH. Presented at: AAAAI 2026 Annual Meeting, February 27-March 2, Philadelphia, Pennsylvania. Abstract #L22

2. Smith T. FDA Approves Omalizumab as First Treatment of 1 or More Food Allergies for Children, Adults. Article. HCPLive. February 16, 2024. 

https://www.hcplive.com/view/fda-approves-omalozumab-first-treatment-of-1-or-more-food-allergies-for-children-adults

Wood discussed the latest long term data from OUtMATCHat AAAAI 2026.

Conference

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Food Allergy

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Brajan Budini is a medical student at the School of Clinical Medicine and Trinity College, University of Cambridge.

Budini discusses his recent study investigating the trajectory of weight regain after GLP-1 cessation, given current high discontinuation rates.

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

Discontinuing GLP-1 Treatment Associated With Up to 60% Weight Regain, With Brajan Budini

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

February 2026 saw new data and expert interviews from AAAAI 2026.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

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COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

6 Pulmonology Headlines You Missed in February 2026

The FDA accepted Mineralys Therapeutics’ NDA for lorundrostat in hypertension, but the selective aldosterone synthase inhibitor fell short in a phase 2 obstructive sleep apnea trial.

Hypertension

The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Lorundrostat Secures FDA NDA Acceptance for Hypertension, Falls Short in Phase 2 OSA Trial

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

Phase 3 RAINIER exhibits positive results for povetacicept in adults with IgA Nephropathy in a 36 week interim analysis.

IgA Nephropathy

The HCPLive Berger disease page is a resource for medical news and expert insights on IgA nephropathy. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in Berger disease, and more.

Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

RAINIER: Povetacicept Reduces Proteinuria By 52.0%

Shahinian is a Dr. Robert H and Eva M Moyad Research Professor of UrologyCo-Chief of Dow Division of Health Services ResearchProfessor of Internal Medicine, and Professor of Urology at the University of Michigan Medical School. 

Having a primary care provider may be associated with reduced emergency department utilization for patients with ESKD receiving dialysis, according to new research. 

Chronic Kidney Disease

Having a Primary Care Provider Linked to Reduced ED Visits for ESKD, With Vahakn Shahinian

A trio of experts discuss how simplifying hepatitis B guidance could help more clinicians diagnose, treat, and support patients living with chronic infection.

Hepatology

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Hepatitis C page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis C virus research, treatment, and drug development.

Empowering More Clinicians to Treat Hepatitis B

Désirée Larenas-Linnemann, MD, from Hospital Médica Sur

At AAAAI 2026, Larenas-Linnemann discusses evidence, safety, and long-term benefits of sublingual immunotherapy for allergic rhinitis and asthma.

Seasonal Allergy

Sublingual Immunotherapy for Allergy in 2026, With Désirée Larenas-Linnemann, MD

Williams explains colorectal cancer screening options, persistent barriers to uptake, and strategies to improve screening rates.

Gastroenterology

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, IBS and IBD, Crohn's disease, and more.

Colorectal Cancer Screening in 2026: Progress, Gaps, and What Comes Next, With Renee Williams, MD

An economic model suggest using lower quality, but acceptable kidneys for older adults may be cost efficective and clinically valuable.

Using Lower Quality Kidneys to Reduce Costs, Increase Transplants for Older Adults, With Matthew Kaufmann, PhD

Nicole Ramsey, MD, PhD, assistant professor of pediatrics in the division of pediatric allergy and immunology at the Icahn School of Medicine at Mount Sinai.

Using race-neutral spirometry equations such as GLI 2012 and GLI 2022 may improve diagnostic accuracy and reduce disparities in lung disease assessment.

Latest News

FDA Approves Leucovorin Calcium (Wellcovorin) Tablets as First Cerebral Folate Deficiency Treatment

Skin of Color Savvy: Challenges and Successes in a Dermatologist’s Career, With Nicole Negbenebor, MD

Colorectal Cancer Screening and Surveillance Decisions

Shifting Epidemiology and Risk Factors in Colorectal Cancer

OUtMATCH: Omalizumab and OIT Similarly Enable Allergenic Food Consumption, With Robert Wood, MD