Tonmya Approved for Fibromyalgia

On Aug. 15, 2025, the US Food and Drug Administration (FDA) approved Tonix Pharmaceuticals’ Tonmya^™ (cyclobenzaprine hydrochloride) sublingual tablets for the treatment of fibromyalgia in adults. Fibromyalgia is a chronic pain disorder affecting over 10 million American adults, primarily women. Tonmya is a reformulated cyclobenzaprine, a skeletal muscle relaxant approved to relieve muscle spasm in tablet form. Tonmya allows for rapid absorption and bypasses liver metabolism, which may reduce long-term side effects. Tonmya offers a new mechanism of action targeting non-restorative sleep, a key driver of fibromyalgia-related pain, unlike existing treatments that address symptoms. Tonmya significantly reduced daily pain scores at 14 weeks compared to placebo, with a greater proportion of patients achieving at least a 30% reduction in pain and showing improvements in sleep disturbance and fatigue. The drug demonstrated a favorable safety profile. The recommended dose is 5.6mg under the tongue nightly at bedtime. Here is the prescribing information.

Wegovy Granted Accelerated Approval for MASH

The FDA granted accelerated approval to Wegovy^® (semaglutide – Novo Nordisk) 2.4mg injection on Aug. 15, 2025, for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. This new indication marks the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved for this indication and Wegovy’s third indication after obesity and cardiovascular risk reduction. MASH, a progressive liver disease linked to metabolic conditions such as obesity, type two diabetes, hypertension, and high cholesterol, affects an estimated 15 million Americans and occurs independently of alcohol use. Wegovy offers a novel approach by mimicking the GLP-1 hormone to reduce liver fat and inflammation compared to Rezdiffra^® (resmetirom – Madrigal), which targets the liver directly. The ESSENCE trial showed that 63% of patients achieved resolution of steatohepatitis with no worsening of fibrosis, and 37% showed fibrosis improvement without worsening of steatohepatitis – both significantly outperforming placebo. A secondary endpoint showed that 33% of patients achieved both outcomes versus 16% of patients taking placebo. The ESSENCE trial, which assesses long-term liver outcomes, is ongoing and expected read out in 2029 as the confirmatory trial for continued approval. The recommended dose is 2.4mg once weekly by subcutaneous (SC) injection, alongside a reduced-calorie diet and increased physical activity. Several investigational agents, including Mounjaro^® (tirzepatide – Eli Lilly), are progressing through clinical development for the treatment of MASH. The updated prescribing information may be found here.

FluMist for At-Home Use Now Available

On Aug. 15, 2025, AstraZeneca announced the launch of FluMist^® Home Service, introducing the first flu vaccine in the United States available for at-home use and direct-to-consumer (DTC) delivery. FluMist Quadrivalent (Influenza Vaccine Live, Intranasal) is approved for self-administration in adults aged 18 to 49 years and caregiver administration in children aged two years to 17 years of age. Initially approved in 2003 for administration by a healthcare professional, the newly launched FluMist Home service allows eligible individuals to order the nasal spray online, complete a medical screening and receive the vaccine by mail, with instructions for refrigeration and self-administration. FluMist remains the only FDA-approved needle-free flu vaccine, offering an alternative to injectable options. Approval was supported by a usability study demonstrating safe and effective self-administration. The vaccine is now available in 34 states for at-home use, with plans to expand nationwide in future seasons. It also remains available by healthcare professional administration across the US. FluMist Home charges $8.99 for physician review and shipping, with most insurance plans covering the vaccine cost. The vaccine will be shipped by Polaris Pharmacy Services with the first available delivery date listed as Sept. 13, 2025. Prescribing information can be found here.

Policy Updates

HHS Reinstates Childhood Vaccine Safety Task Force Amid Controversy and Policy Shifts

On Aug. 14, 2025, the US Department of Health and Human Services (HHS) announced the reinstatement of the Task Force on Safer Childhood Vaccines, a panel originally created by Congress about 40 years ago and disbanded in 1998. The revived task force includes leadership from the National Institutes of Health (NIH), the FDA and the Centers for Disease Control and Prevention (CDC) and will collaborate with the Advisory Commission on Childhood Vaccines to refine vaccine development and reduce adverse reactions. The move aligns with HHS Secretary Robert F. Kennedy Jr.’s broader agenda to reevaluate the current childhood immunization schedule, a long-standing goal of his anti-vaccine advocacy. The task force is expected to deliver its first report to Congress within two years.

Recall

Gamunex-C Recalled

On Aug. 8, 2025, Grifols Therapeutics LLC withdrew two lots of Gamunex-C^® (immune globulin injection [human], 10% caprylate/chromatography purified) 20G vials to the consumer level due to an increased rate of reported hypersensitivity reactions with the affected lots. This follows similar withdrawals on Feb. 19 and March 21, 2025, for the same reason. Gamunex-C is an immune globulin solution indicated for treating primary humoral immunodeficiency (PI) in patients two years of age or older, idiopathic thrombocytopenic purpura (ITP) in adults and children and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Hypersensitivity and anaphylactic reactions are listed in the warnings and precautions section of the prescribing information; however, these lots may pose a higher risk for these reactions. For more details, see here.

Celltrion Recalls One Lot of Steqeyma

On Aug. 13, 2025, Celltrion USA initiated a recall of one lot of Steqeyma^® (ustekinumab-stba) 90 mg/mL injection due to incorrect assembly and release into the market. Steqeyma is a human interleukin-12 and -23 antagonist indicated for the treatment of adult patients who have moderate to severe plaque psoriasis (PsO) and are candidates for phototherapy or systemic therapy, active psoriatic arthritis (PsA), moderately to severely active Crohn’s disease (CD) and moderately to severely active ulcerative colitis. It is also indicated for pediatric patients ages six years and older who have moderate to severe plaque psoriasis and are candidates for phototherapy or systemic therapy, as well as those who have active PsA. For more information on the recall, see here.

B. Braun Recalls Two IV Fluids On Aug. 20, 2025, B. Braun issued a recall notification for two injectable products, Sodium Chloride 0.9% E3 Injection (12 x 1000 mL) and Lactated Ringer’s Injection (12 x 1000 mL). The recall was initiated due to the potential presence of particulate matter in solution, which may pose a risk to patient safety. Sodium Chloride 0.9% Injection is used as a sterile vehicle for diluting or reconstituting medications for intravenous (IV) administration, or for treating metabolic alkalosis in the presence of fluid loss and mild sodium depletion. Lactated Ringer’s Injection is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. For more information, see here.