--- title: PDR Drug Update - May 2026 description: The PDR Labeling Updates provide physicians with the latest FDA recalls, warnings and approval information - available in PDR's monthly eDrug Update --- # May 2026 PDR Drug Update  Type Drug Name Here Search - Lead Story - Latest FDA News - FDA Drug Information Changes - FDA Safety - Labeling Updates Lead Story ##### **Continued Growth in Oral Incretin-Based Therapy Options ** Pharmacologic management of obesity and type 2 diabetes mellitus is rapidly evolving. GLP-1 injectable drugs dominate prescribing, but no single approach fits all. New treatment options benefit patients who need individualized care. Many find injectable GLP-1 medications effective and advantageous, but these drugs can present barriers. Some patients avoid needles, making it hard to start or stick to dosing that requires injections. Pill formulations of semaglutide mimic incretin hormones to reduce appetite, delay gastric emptying, and improve blood sugar regulation like their injectable counterparts. Oral options are less effective than injectables, but pills offer dosing flexibility that can make a significant difference for patients managing health issues. [Foundayo (orforglipron)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf) is the most recent addition to the class of oral GLP-1 therapies. The FDA approved the drug for use with a reduced-calorie diet and increased physical activity to help adults with obesity or overweight (plus at least one weight-related comorbid condition) lose excess weight and maintain long-term reduction. Orforglipron is a small-molecule, non-peptide compound. Orforglipron tablets work like GLP-1 receptor agonists, increasing appetite control and glucose regulation, and slowing gastric emptying. Other oral GLP-1 medications require fasting in the morning to ensure absorption, but orforglipron skips this requirement. The simplified dosing may help more patients adhere to therapy. A phase 3, randomized, double-blind, placebo-controlled clinical trial supported orforglipron’s approval. Study results showed participants taking the highest dose of orforglipron lost an average of 12.4% of their body weight, while participants on placebo lost 0.9%. A [priority voucher program](https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program) established to help address public health needs expedited orforglipron’s approval process. The FDA’s [approval letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220934Orig1s000ltr.pdf) included postmarketing requirements for continued research. Investigators must conduct additional clinical trials to understand orforglipron’s cardiovascular and liver safety better. They will also study delayed gastric emptying and assess drug concentrations in breast milk. Expanding the drug’s label to more indications will depend on future research. When adding orforglipron to clinical practice, healthcare providers should consider patient-specific factors such as glycemic targets, weight management goals, tolerability, and preferences for administration route. As researchers publish new data, especially regarding cardiovascular outcomes and long-term safety, orforglipron’s role within treatment guidelines will likely evolve. Stay informed about emergent drug information, including GLP-1-based therapies, by exploring [PDR by ConnectiveRx](https://www.pdr.net/?hsLang=en). You can also download the official PDR app, [*mobile*PDR](https://www.pdr.net/mobilepdr/?hsLang=en), available for free from your preferred app store. Latest FDA News ### FDA New Approvals ##### Avlayah The FDA has approved Avlayah (tividenofusp alfa-eknm), an enzyme replacement therapy indicated for the treatment of neurologic manifestations of Hunter syndrome (mucopolysaccharidosis type II, or MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5kg prior to advanced neurologic impairment. [Learn more about Avlayah](https://investors.denalitherapeutics.com/news-releases/news-release-details/denali-therapeutics-announces-us-fda-approval-avlayahtm) ##### Awiqli The FDA has approved Awiqli (insulin icodec-abae) injection 700 units/mL, a once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycemic control in adults living with type 2 diabetes. [Learn more about Awiqli](https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916522) ##### Foundayo The FDA has approved Foundayo (orforglipron) for adults with obesity, or overweight with weight-related medical problems. [Learn more about Foundayo](https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-foundayotm-orforglipron-only-glp-1-pill) ##### Kresladi The FDA has approved Kresladi (marnetegragene autotemcel), an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of pediatric patients with severe leukocyte adhesion deficiency-I due to biallelic variants in *ITGB2* without an available human leukocyte antigen-matched sibling donor for allogeneic hematopoietic stem cell transplant. [Learn more about Kresladi](https://ir.rocketpharma.com/news-releases/news-release-details/rocket-pharmaceuticals-announces-fda-approval-kresladitm) ##### Lifyorli The FDA has approved Lifyorli (relacorilant) in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. [Learn more about Lifyorli](https://ir.corcept.com/news-releases/news-release-details/fda-approves-corcepts-selective-glucocorticoid-receptor) ##### Ponlimsi The FDA has approved Ponlimsi (denosumab-adet) as a biosimilar to Prolia (denosumab), for all Prolia indications. [Learn more about Ponlimsi](https://www.tevausa.com/news-and-media/press-releases/teva-gains-biosimilar-momentum-with-u.s.-fda-approval-of-ponlimsi-denosumab-adet-and-dual-filing-accep) ### FDA New Indications ##### Filspari The FDA has approved Filspari (sparsentan) for reduction of proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis without nephrotic syndrome. [Learn more about Filspari](https://ir.travere.com/press-releases/news-details/2026/Travere-Therapeutics-Announces-Full-FDA-Approval-of-FILSPARI-sparsentan-the-First-and-Only-Approved-Medicine-for-FSGS/default.aspx) ##### Imcivree The FDA has approved an expanded indication for Imcivree (setmelanotide) to reduce excess body weight and maintain reduction long-term in adults and pediatric patients aged 4 years and older with acquired hypothalamic obesity. [Learn more about Imcivree](https://ir.rhythmtx.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-fda-approval-imcivreer-1) ##### Opdivo The FDA has approved Opdivo (nivolumab) in combination with doxorubicin, vinblastine, and dacarbazine for the treatment of adult and pediatric patients aged 12 years and older with previously untreated, Stage III or IV classical Hodgkin Lymphoma. [Learn more about Opdivo](https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Transforms-the-Classical-Hodgkin-Lymphoma-Treatment-Paradigm-with-Expanded-U-S--and-EMA-Approvals-for-Opdivo-nivolumab/default.aspx) FDA Drug Information Changes ### FDA Labeling Changes ##### Adstiladrin The FDA has approved a label update for Adstiladrin (nadofaragene firadenovec-vncg), enabling an accelerated water-bath thawing method, completed in about 25 minutes, to enhance efficient clinical preparation for healthcare teams. [Learn more about Adstiladrin](https://ferringusa.com/?press=u-s-fda-approves-label-update-to-accelerate-thaw-time-for-adstiladrin-nadofaragene-firadenovec-vncg) ##### Alyftrek and Trikafta The FDA has approved expanded use of Alyftrek (vanzacaftor/tezacaftor/ deutivacaftor) for the treatment of people with cystic fibrosis (CF) aged 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or *in vitro* data or results in production of *CFTR* protein. Additionally, the FDA has also expanded the indication statement for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients aged 2 and older. [Learn more about Alyftrek and Trikafta](https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-approval-label-extensions-alyftrekr-and) ##### Neffy The FDA has approved an update to the Neffy (epinephrine) nasal spray prescribing information to remove the age criteria so all children and adults who weigh 33 lbs or more can utilize Neffy for the emergency treatment of Type 1 allergic reactions, including anaphylaxis. Additionally, the label update recommends that patients carry Neffy in the blister packaging or in the Neffy carrying case. [Learn more about Neffy](https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-remove-age-requirement) ### FDA New Formulations ##### Spinraza The FDA has approved a high-dose regimen of Spinraza (nusinersen), which is comprised of 50mg/5mL and 28mg/5mL doses, for the treatment of spinal muscular atrophy. [Learn more about Spinraza](https://investors.biogen.com/news-releases/news-release-details/fda-approves-new-high-dose-regimen-spinrazar-nusinersen-spinal) ### FDA New Dosing ##### Eylea HD The FDA has approved the extension of dosing intervals for Eylea HD (aflibercept) up to every 20 weeks for patients with wet age-related macular degeneration and diabetic macular edema following one year of successful response based on visual and anatomic outcomes. [Learn more about Eylea HD](https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-approved-fda-first-and-only-injectable) ##### Vabysmo The FDA has approved Vabysmo (faricimab-svoa) for the treatment of macular edema due to retinal vein occlusion beyond six months. [Learn more about Vabysmo](https://www.gene.com/media/statements/ps_040926) FDA Safety ### FDA Recalls ##### Amneal Pharmaceuticals Magnesium Sulfate Amneal Pharmaceuticals LLC is voluntarily recalling one lot of magnesium sulfate in water for injection, USP, 4g/100mL, IV bag, to the hospital level. A magnesium sulfate in water for injection pouch was found to contain an IV bag of tranexamic acid in 0.7% sodium chloride injection, 10mg/mL. [Learn more about the magnesium sulfate recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-magnesium-sulfate-water-injection-usp) ##### Aphreseller Kian Pee Wan Aphreseller (eBay seller ID), Buy-herbal.com is recalling all lots of Kian Pee Wan capsules to the consumer level. FDA analysis has found that the product contains the undeclared drug ingredients dexamethasone and cyproheptadine. [Learn more about the Kian Pee Wan recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aphreseller-buy-herbalcom-issues-voluntary-nationwide-recall-kian-pee-wan-capsules-due-presence) ##### Blaine Labs Revitaderm and Tridergel Wound Care Gel Blaine Labs, Inc. is voluntarily recalling three lot numbers of wound care gel products, 1 oz and 3 oz (0.1% benzalkonium chloride), to the consumer level due to microbial contamination. The affected products have been found to contain *Lysinibacillus fusiformis*, an environmental organism. [Learn more about the Revitaderm and Tridergel recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blaine-labs-inc-issues-voluntary-nationwide-recall-wound-care-gel-products-due-microbial) ##### Cardinal Health Webcol Large Alcohol Prep Pads Cardinal Health has issued a voluntary recall for select lots of Webcol large alcohol prep pads (70% isopropyl alcohol) to the consumer level. The product is being recalled due to microbial contamination identified as *Paenibacillus phoenicis*. [Learn more about the Webcol recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-issues-voluntary-nationwide-recall-webcoltm-large-alcohol-prep-pad) ### FDA Drug Safety Communications ##### Tavneos The FDA is alerting patients and healthcare professionals about serious postmarketing cases, including fatal cases, of drug-induced liver injury (DILI) associated with Tavneos (avacopan). Some cases involved vanishing bile duct syndrome (VBDS). The FDA is continuing to monitor postmarketing cases of DILI, including VBDS, involving Tavneos and will provide updates as appropriate. [Learn more about the Tavneos drug safety communication](https://www.fda.gov/drugs/drug-safety-communications/fda-identifies-cases-serious-liver-injury-patients-taking-tavneos-avacopan-severe-active-anti) ### FDA REMS ##### Ponlimsi The FDA has approved a REMS for Ponlimsi (denosumab-adet). The goal of the Ponlimsi REMS is to mitigate the risk of severe hypocalcemia in patients with advanced chronic kidney disease, including dialysis-dependent patients, associated with Ponlimsi. [Learn more about Ponlimsi](https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ponlimsi_2026_03_27_REMS_Full.pdf) Labeling Updates ##### Labeling Updates - No updates this month ```json { "@context" : "https://schema.org", "@id" : "https://www.pdr.net#website", "@type" : "Website", "name" : "", "potentialAction" : { "@type" : "SearchAction", "query-input" : "required name=search_term_string", "target" : { "@type" : "EntryPoint", "urlTemplate" : "https://www.pdr.net/?site-search={search_term_string}" } }, "publisher" : { "@id" : "https://www.pdr.net#organization" }, "url" : "https://www.pdr.net" } ``` ```json { "@context" : "https://schema.org", "@id" : "https://www.pdr.net/edrug-updates/may2026#webpage", "@type" : "WebPage", "about" : { "@id" : "https://www.pdr.net#organization" }, "dateModified" : "2024-10-01T12:0000+0000", "datePublished" : "2026-05-04T13:4956+0000", "description" : "The PDR Labeling Updates provide physicians with the latest FDA recalls, warnings and approval information - available in PDR's monthly eDrug Update\t", "inLanguage" : null, "isPartOf" : { "@id" : "https://www.pdr.net#website" }, "name" : "PDR Drug Update - May 2026", "url" : "https://www.pdr.net/edrug-updates/may2026" } ```