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Monthly News Roundup - August 2025

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Aug 31, 2025.

Wegovy Granted Accelerated Approval as First GLP-1 Treatment for the Treatment of MASH

Novo Nordisk’s Wegovy (semaglutide) has received US Food and Drug Administration (FDA) accelerated approval for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults.

• Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist also used for weight management and cardiovascular risk reduction in people with obesity or overweight.
• MASH is a progressive ongoing disease affecting the liver, causing liver inflammation and damage caused by a buildup of fat in the liver. It can progress to liver cancer and become fatal if not properly managed. It is a more advanced form of nonalcoholic fatty liver disease (NAFLD). People living with MASH often experience few or no specific symptoms in early disease, which often results in a delayed diagnosis.
• Accelerated approval was based on part 1 of the ESSENCE trial that showed statistically significant results at week 72, with 36.8% of those on Wegovy achieving improvement in liver fibrosis with no worsening of steatohepatitis vs. 22.4% on a placebo. In addition, 62.9% of people treated with Wegovy achieved resolution of steatohepatitis with no worsening of liver fibrosis vs. 34.3% treated with placebo.
• For patients with MASH, the Wegovy maintenance dosage is 2.4 mg injected subcutaneously (under the skin) once weekly, with or without food. If patients do not tolerate 2.4 mg once weekly, the dosage can be decreased to 1.7 mg once weekly. Wegovy is used in addition to diet and increased physical activity.
• The Wegovy product label carries a boxed warning for an increased risk of thyroid C-cell tumors.
• Warnings and precautions include acute pancreatitis, acute gallbladder disease, hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy complications in patients with type 2 diabetes, increased heart rate, and suicidal behavior and ideation, and pulmonary aspiration during general anesthesia or deep sedation.
• The most common side effects include: nausea / vomiting, diarrhea, constipation, abdominal (stomach-area) pain, headache, tiredness, heartburn, dizziness, bloating, gas, belching, low blood sugar in patients with type 2 diabetes, stomach upset / infection, reflux, and runny nose or sore throat.
• The indication for MASH is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval may be contingent upon the determination of clinical benefit in a confirmatory trial.

FDA Approves Tonmya Sublingual Tablets for the Treatment of Fibromyalgia

In August, the FDA cleared Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya, from Tonix Pharmaceuticals, is the first new FDA-approved therapy for this use in over 15 years.

• Tonmya is a once-daily, non-opioid analgesic with a unique sublingual (placed under the tongue) formulation that is designed for rapid absorption into the bloodstream. Tonmya tablets are administered sublingually once daily at bedtime.
• Fibromyalgia is a common chronic pain condition thought to result from amplified sensory and pain signaling within the central nervous system. Symptoms include long-term widespread pain, sleep disturbances, fatigue, and brain fog (or cognitive dysfunction).
• Tonmya contains cyclobenzaprine HCL), which is thought to improve the non-restorative sleep characteristic of fibromyalgia through potent binding and antagonist activities at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors.
• Tonmya is a rapidly-disintegrating, sublingual formulation of cyclobenzaprine hydrochloride 2.8 mg designed for bedtime dosing to target disturbed sleep in fibromyalgia patients, while reducing the risk of daytime somnolence. It is based on a specialized (eutectic) formulation of cyclobenzaprine and mannitol that provides a stable product and dissolves rapidly to deliver cyclobenzaprine efficiently into the bloodstream. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine formulations, Tonmya provided a rapid onset of action, avoided first-pass hepatic metabolism, and reduced the formation of norcyclobenzaprine (nCBP), a long-acting metabolite which is associated with unfavorable side effects.
• FDA approval of Tonmya was supported by efficacy data from RELIEF and RESILIENT Phase 3 clinical trials of nearly 1,000 patients. Across both trials, Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain after 3 months, compared to placebo.
• Warnings and precautions associated with Tonmya include embryofetal toxicity, serotonin syndrome, tricyclic antidepressant-like adverse reactions, atropine-like adverse reactions, CNS depression, and oral mucosal adverse reactions.
• Common adverse reactions include oral numbness / tingling, oral discomfort, abnormal product taste, somnolence (sleepiness), oral pain, fatigue, dry mouth, and aphthous ulcer (“canker sore”).
• Oral cyclobenzaprine was first approved in 1977 for the relief of skeletal muscle spasms, also known under the brand names Flexeril (brand discontinued), Amrix and generic options.
• Tonmya is expected to be available in the fourth quarter of 2025.

FDA Approves Expanded Ajovy Use for Episodic Migraine in Children

This past month the FDA approved Ajovy (fremanezumab) for the preventive treatment of episodic migraine in children who are 6 to 17 years of age and who weigh 45 kg (99 lbs) or more. It is the firs tanti-CGRP preventive treatment for pediatric episodic migraine. It was formerly approved in Sept. 2018 for the preventive treatment of migraine in adults.

• One in 10 children and adolescents in the U.S. suffer from migraine, one of the most common neurological conditions. Migraine attacks cause disabling pain, nausea, vomiting and sensitivities to light and sound, resulting in difficulty in completing daily tasks. In children, this may affect school attendance, educational performance and social or sporting activities.
• Ajovy is a calcitonin gene-related peptide (CGRP) antagonist that blocks the effect of CGRP, which is a small protein involved in pain transmission during a migraine attack. It may also play a causative role in the induction of migraine attacks.
• Approval was based on Study 3 (NCT 04458857), a randomized, placebo controlled study over a 3-month period in 225 patients. The primary endpoint was the mean change from baseline in the monthly average number of migraine days during the 3-month treatment period. Results showed a reduction in monthly migraine days of 2.5 days with Ajovy vs. 1.4 days with placebo (p=0.021). In addition, the proportion of patients reaching at least a 50% reduction in monthly average number of migraine days during the 3-month treatment period was 47.2% for Ajovy vs. 27% placebo, a significant effect (p=0.002)
• The Ajovy dose for children is 225 given once per month and comes as a single dose in a pre-filled autoinjector or syringe. Ajovy is administered once a month as an injection under the skin (abdomen, thigh, or upper arm) and is available for in-office or at home use (after training by a healthcare provider).
• Warnings include allergic reactions, risk of high blood pressure and risk of Raynaud’s Phenomenon (a condition that causes blood vessels in fingers, toes to temporarily constrict in response to stress or cold).
• Side effects with Ajovy are similar between children and adults and may include injection site reactions and allergic reactions

Repatha Now Indicated for Adults at Increased Risk for Major Adverse Cardiovascular Events Due to Uncontrolled LDL-C

This past month the FDA cleared Amgen’s Repatha (evolocumab), a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as 'bad cholesterol.' This update removes a prior requirement for a patient to have been diagnosed with cardiovascular (CV) disease.

• Specifically, Repatha can now be used to reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events.
• In addition, Repatha's label was expanded to be used alone (monotherapy) in patients with a rare, genetic form of high cholesterol known as homozygous familial hypercholesterolemia (HoFH); and emphasized that Repatha should be used alongside diet and exercise for managing high LDL cholesterol.
• Repatha is also approved as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in:

• • adults with hypercholesterolemia.
  • adults and children aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
  • adults and children aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
• Repatha is administered via subcutaneous (under the skin) injection (into areas of the abdomen, thigh or upper arm) either every 2 weeks or once a month. It comes in 3 dosage forms: as a single-dose autoinjector, as a single-dose on-body infuser (Pushtronex) or in a single-dose syringe. Patients may be taught to administer it home.
• Repatha may cause serious hypersensitivity reactions, including angioedema (rapid swelling in areas like the face, tongue, lips, tongue). Patients should inform their healthcare provider if they are sensitive to latex.
• Common adverse reactions in adults with primary hypercholesterolemia (high cholesterol) include nasopharyngitis (common cold symptoms), upper respiratory tract infection, influenza (flu), back pain, and injection site reactions.

FDA Approves First-in-Class Brinsupri to Treat Non-Cystic Fibrosis Bronchiectasis

This past month the FDA approved Brinsupri (brensocatib), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. Brinsupri is the first FDA-approved treatment for NCFB.

• Bronchiectasis is a chronic lung condition that causes airways to permanently widen, making it harder to clear mucus and bacteria. This can lead to persistent lung inflammation and infection. A hallmark of bronchiectasis is frequent flares when symptoms, such as coughing, mucus production, shortness of breath and fatigue, can worsen.
• Brinsupri is a once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). It is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB.
• Approval is based on the Phase 3 ASPEN and Phase 2 WILLOW studies. In ASPEN, patients taking Brinsupri 10 mg or 25 mg had a 21.1% and 19.4% reduction in their annual rate of exacerbations respectively, as compared to placebo. Secondary endpoints were also met, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period. Patients who received Brinsupri 25 mg experienced statistically significantly less decline in lung function, as measured by forced expiratory volume in one second (FEV₁) after using a bronchodilator, at week 52.
• Warnings and precautions include skin reactions, gingival and periodontal adverse reactions, Patients should avoid the use of live attenuated vaccines.
• The most common adverse reactions (incidence >2%) included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis (skin thickening), and hypertension (high blood pressure).
• Brinsupri is now available by prescription through a specialty pharmacy network.

Papzimeos Cleared for the Treatment of Adults with Recurrent Respiratory Papillomatosis

The FDA has approved Precigen’s Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). Papzimeos is the first FDA-approved therapy for the treatment of adults with RRP.

• RRP is a rare and potentially life-threatening disease of the upper and lower respiratory tract. It can lead to severe voice disturbance, compromised airway, recurrent post-obstructive pneumonias and multiple surgeries. It is caused by chronic human papillomavirus (HPV) 6 or HPV11 infection. Although rare, RRP may also lead to malignant cancer and can be fatal.
• Papzimeos is a non-replicating adenoviral vector-based immunotherapy. It works by expressing a fusion antigen composed of selected regions of HPV6 and HPV11 infected cells to generate an immune response directed against HPV6 and HPV11 proteins.
• Approval was based on the pivotal PRGN-2012-201 study from the National Institutes of Health. Overall, 51% (18 out of 35) of patients achieved a complete and durable response (CR), requiring no surgeries in the 12 months after treatment. Of the 18 patients with a CR in the ongoing study, 15 patients evaluated at 24 months demonstrated continued CR.
• Papzimeos is administered by subcutaneous (under the skin) injection 4 times over a 12-week interval (at 0, 2, 6, and 12 weeks).
• Warnings and precautions associated with Papzimeos include injection site reactions and thrombotic (blood clotting) events.
• Common adverse reactions (incidence ≥5%) include injection site reactions, fatigue, chills, pyrexia (fever), myalgia (muscle pain), and nausea.

FDA Grants Accelerated Approval to Hernexeos for HER2-Mutant Advanced NSCLC

Boehringer Ingelheim’s Hernexeos (zongertinib oral tablets) is now approved for the treatment of adults with unresectable (cannot be removed by surgery) or metastatic (has spread within the body) non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations (detected by an FDA-approved test) and who have received prior systemic therapy.

• Hernexeos is a tyrosine kinase inhibitor (TKI) that works by selectively inhibiting HER2 (ERBB2).
• NSCLC is the most common type of lung cancer. HER2 (ERBB2) mutations occur in approximately 2% to 4% of NSCLC cases and are associated with a poor prognosis and higher risk of spreading to the brain.
• Accelerated approval is based on data from the Phase Ib Beamion-LUNG 1 trial, demonstrating an objective response rate of 75% (N=71), with 6% of patients having a complete response, 69% of patients having a partial response and a duration of response of 6 months or longer in 58% of patients (n=53).
• Hernexeos tablets are administered orally, once daily with or without food until disease progression or unacceptable toxicity.
• Warnings and precautions include hepatotoxicity (liver damage), left ventricular dysfunction (trouble pumping blood from the heart), interstitial lung disease / pneumonitis (lung inflammation), and embryo-fetal toxicity (harm to an unborn baby).
• In safety studies, the most common (>20%) adverse reactions were diarrhea (53%), liver toxicity (27%), rash (27%), fatigue (22%), and nausea (21%).
• This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this use may depend upon results of clinical benefit in a confirmatory study.

Modeyso is the First Treatment Approved for Diffuse Midline Glioma Brain Tumors

The FDA has granted accelerated approval to Jazz Pharmaceuticals' oral Modeyso (dordaviprone) to treat people 1 year of age and older with diffuse midline glioma with an H3 K27M mutation, a type of rare, aggressive brain tumor that often affects children. Modeyso is used in patients whose disease has progressed after previous therapy.

• Modeyso is a protease activator that helps to slow cancer growth and causes cancer cells to die. Modeyso works by activating an enzyme called mitochondrial caseinolytic protease P (ClpP) and inhibiting the dopamine D2 receptor.
• A glioma is a brain tumor that originates from glial cells found in the central nervous system. The H3 K27M mutation is a specific mutation in one of the genes that encode for proteins called histone H3. The mutation is found in the majority of diffuse midline gliomas.
• Accelerated approval of Modeyso was based on a pre-specified integrated efficacy analysis of 50 adult and pediatric patients with recurrent H3 K27M-mutant diffuse midline glioma enrolled across five open-label clinical studies (ONC006, ONC013, ONC014, ONC016, and ONC018). Modeyso showed an overall response rate (ORR) of 22% with a median duration of response (DOR) of 10.3 months. Of those with objective responses, 73% had a response duration of at least 6 months, and 27% had a response duration of at least 12 months.
• Modeyso is taken by mouth as a capsule once a week, swallowed whole on an empty stomach (at least 1 hour before or 3 hours after eating). It is continued until the disease progresses or there are unacceptable side effects.
• Warnings and precautions include allergic reaction or anaphylaxis (severe, life-threatening allergy), QTc interval prolongation (abnormal heart rhythm), and embryo-fetal toxicity (harm to an unborn baby).
• Common adverse reactions (in at least 20% of study participants) include fatigue, headache, vomiting, nausea, and muscle / bone pain. Common Grade 3 or 4 laboratory abnormalities include decreased lymphocytes (white blood cells), decreased calcium, and increased alanine aminotransferase (a liver enzyme).
• Continued approval for this indication may depend upon clinical benefit in the Phase 3 ACTION (NCT05580562) trial, which is evaluating the safety and clinical benefit of Modeyso in newly diagnosed patients with H3 K27M-mutant diffuse glioma following radiotherapy.

FDA Approves Dawnzera to Prevent Hereditary Angioedema Attacks

In August, Ionis Pharmaceuticals announced the FDA approval of Dawnzera (donidalorsen) for prophylaxis (for prevention) of attacks of hereditary angioedema (HAE) in people 12 years of age and older.

• Hereditary angioedema (HAE) is a rare, genetic and potentially life-threatening condition caused by a lack of or damaged C1INH, a protein in the blood that helps to control inflammation. Symptoms include painful, recurrent and unpredictable attacks of swelling (angioedema) that may affect the face, stomach area, larynx (voice box), and extremities like hands, arms and legs.
• Dawnzera is the first RNA-targeted medicine approved for HAE. It is designed to target plasma prekallikrein (PKK), a key protein that contributes to inflammation associated with acute attacks of HAE.
• Approval was based on positive results from the Phase 3, double-blind, placebo-controlled OASIS-HAE study with 90 patients. The primary endpoint was the HAE attack rate (number of investigator-confirmed HAE attacks per 4 weeks) from Week 0 to Week 24. The study met its primary endpoint, with Dawnzera given every 4 weeks significantly reducing monthly HAE attack rate by 81% compared to placebo over 24 weeks.
• The recommended dosage is 80 mg given subcutaneously (under the skin) every 4 weeks; 80 mg subcutaneously every 8 weeks may be considered. Use in patients with moderate and severe hepatic impairment is not recommended Dawnzera is self-administered using a single-dose autoinjector, meaning the patient or caregiver can administer at home, after training.
• Warnings and precautions associated with Dawnzera include hypersensitivity (allergic) reactions including anaphylaxis (life-threatening type of allergic reaction that requires immediate medical attention).
• The most common adverse reactions (incidence ≥ 5%) were injection site reactions, upper respiratory tract infection, urinary tract infection and abdominal (stomach area) discomfort.

FDA Approves KETARx (ketamine) for Surgical Pain Management

In August, the FDA cleared KETARx (ketamine hydrochloride), a general anesthetic injection for use in surgical pain management manufactured by PharmaTher Holdings Ltd. Since February 2018, ketamine has been regularly listed on the FDA drug shortage list.

• Ketamine is not an opioid (narcotic); it is an NMDA receptor antagonist, which means it works by blocking the N-methyl-D-aspartate (NMDA) neurotransmitter in the brain.
• In addition to surgical pain management, ketamine is also FDA-approved as an anesthetic to put you to sleep for surgery. Its use for depression is currently being researched in clinical trials. It is also a recreational drug of abuse used illegally for its hallucinogenic properties and is used as a “date rape” drug due to a short-term memory loss side effect.
• This approval may also open new options for mental health disorders and pain management such as neurological disorders such as Parkinson's disease and Amyotrophic Lateral Sclerosis (ALS), and the management of rare or chronic pain, including Complex Regional Pain Syndrome (CRPS).
• Ketamine is on the World Health Organization Essential Medicines List, with its global market projected to grow from $750 million to $3.42 billion by 2034.

Posted August 2025

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