High Dose Wegovy (Wegovy HD) for Weight Loss
Novo Nordisk’s higher dose (7.2 mg) version of Wegovy (semaglutide) injection, Wegovy HD, was approved for weight reduction in adults with obesity or for overweight adults with at least one weight-related condition. Previously, the highest dose for the Wegovy injection was 2.4 mg. The higher dose resulted in additional average weight loss compared to previously approved doses.
An unusual side effect with this medication is under FDA review: reports of altered skin sensation (described as sensitivity, pain, or burning) were common, and occurred more frequently at the higher Wegovy dosage than lower dosages.
FDA Press Release: Higher Dose Semaglutide Approval
Wegovy HD was approved in less than two months under the expedited Commissioners National Priority Voucher Pilot (CNVP) program.
The FDA is hosting a hearing about the CNVP program on June 12, 2026, to allow stakeholders to present information and views about the program.
FDA Hearing Announcement on CNVP Program
New Tablets Offer Alternative to Injectables like Skyrizi for Plaque Psoriasis
Johnson & Johnson’s Icotyde (icotrokinra) tablets were approved to treat moderate to severe plaque psoriasis in patients aged 12 and up weighing at least 40 kg (88 pounds). The supporting clinical trials compared icotrokinra against placebo and deucravacitinib (brand name Sotyktu). Notably, twice as many patients achieved complete skin clearance with icotrokinra compared with deucravacitinib. This medication could be an option for patients who prefer a daily pill instead of a quarterly (every 3 months) injection such as AbbVie’s Skyrizi.
FDA Approval Letter
Pharmacy Times: Icotrokinra approved
Drug Label for Icotyde
Lynavoy for Liver Condition Causing Itching
GSK’s Lynavoy (linerixibat) tablets were approved for the treatment of cholestatic pruritus (itching sensation due to bile accumulation) associated with primary biliary cholangitis (PBC) in adult patients. PBC is a rare autoimmune liver disease in which bile flow from the liver is progressively disrupted due to inflamed bile ducts. Bile ducts are tubes that move bile from the liver to the small intestine to help with digestion. GSK says this is the first drug approved in the U.S. for this indication.
FDA Approval Letter
GSK Press Release
MedlinePlus: Primary Biliary Cholangitis
Yuviwel for Growth in Children with Achondroplasia
Ascendis Pharma’s Yuviwel (navepegritide) subcutaneous injection was approved to improve growth in patients aged two years and older with achondroplasia (the most common form of dwarfism) with open epiphyses (growth plates). This approval was granted under the accelerated approval pathway based on improvement in annualized growth velocity (AGV), which measures the rate of height growth. A confirmatory trial is ongoing to determine whether Yuviwel also improves final adult height.
Achondroplasia is a genetic condition that causes short stature and disproportionate growth. The average height of an adult with achondroplasia is approximately four feet. It occurs in about 1 in 10,000 to 1 in 30,000 live births per year. Yuviwel is administered subcutaneously once a week, with dosage based on body weight.
FDA Announcement
on Achondroplasia treatment
FDA Drug Overview
Yuviwel Drug Label
Expanded Approval: Wellcovorin (Leucovorin Calcium) for Cerebral Folate Deficiency
GSK’s Wellcovorin (leucovorin calcium) tablets were approved for the treatment of cerebral folate deficiency in adult and pediatric patients with a confirmed variant in the folate receptor 1 gene (CFD-FOLR1). Although leucovorin has been approved since 1952, this marks the return of the Wellcovorin brand, which had been discontinued for years. The approval was based on literature reviews and case studies.
Cerebral folate deficiency is a neurological condition that affects folate (a vitamin essential for brain health) transport into the brain. People with CFD-FOLR1 often experience severe developmental delays, movement disorders, seizures, and other neurological problems. This approval supports the FDA’s effort to address symptoms associated with autism spectrum disorders.
FDA Announcement on Autism-Related Treatments
FDA Press Release
on Wellcovorin approval
FDA Approval Letter
Revised Drug Label
