Formulary Watch |

Formulary Watch covers formularies, pharmacy benefit management companies, drug approvals, and other matters related to medications, their prices and insurance coverage.

Editorial Contact: Denise Myshko: dmyshko@mjhlifesciences.com

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FDA Grants Accelerated Approval of Wegovy to Treat Liver Disease
FDA Grants Accelerated Approval of Wegovy to Treat Liver Disease
August 18, 2025
Wegovy is the first GLP-1 drug approved to treat adults with metabolic dysfunction-associated steatohepatitis (MASH). An ongoing study aims to confirm the benefits.
FDA Approves Recurrent Respiratory Papillomatosis Treatment, Papzimeos
FDA Approves Recurrent Respiratory Papillomatosis Treatment, Papzimeos
FDA Approves Recurrent Respiratory Papillomatosis Treatment, Papzimeos
August 15, 2025
Papzimeos is the first and only FDA-approved treatment for adults with recurrent respiratory papillomatosis (RRP), with ongoing clinical studies showing symptom relief for up to two years.
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Medicare Plans Face Higher Liability From Cap on Out-of-Pocket Drug Costs
Medicare Plans Face Higher Liability From Cap on Out-of-Pocket Drug Costs
August 14, 2025
To help Medicare plans better manage members with high drug expenses, Prime Therapeutics has launched an AI-driven tool to help plans identify members likely to experience increases in pharmacy costs.
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Employers Project 10% Rise in Healthcare Costs for 2026
Employers Project 10% Rise in Healthcare Costs for 2026
August 14, 2025
Managing specialty and cancer drugs, as well as the GLP-1 therapies, tops the list of priorities this year and next, according to a survey by the International Foundation of Employee Benefit Plans.
Medication Prior Authorization Biggest Daily Challenge for 1 in 5 Prescribers, Survey Says
Medication Prior Authorization Biggest Daily Challenge for 1 in 5 Prescribers, Survey Says
Medication Prior Authorization Biggest Daily Challenge for 1 in 5 Prescribers, Survey Says
August 12, 2025
Pharmacists and prescribers express ongoing concern about medication prior authorization struggles, but most are willing to adopt new technologies to ease the burden, according to a recent Surescripts survey.
FDA Approves First Treatment for Chronic Inflammatory Lung Condition
FDA Approves First Treatment for Chronic Inflammatory Lung Condition
FDA Approves First Treatment for Chronic Inflammatory Lung Condition
August 12, 2025
Brinsupri is the first approved therapy to address the underlying inflammatory process of non-cystic fibrosis bronchiectasis (NCFB).
FDA Approves Ajovy for Childhood Migraine Prevention
FDA Approves Ajovy for Childhood Migraine Prevention
FDA Approves Ajovy for Childhood Migraine Prevention
August 7, 2025
Teva's Ajovy gains FDA approval for pediatric migraine prevention, offering hope for children aged 6-17 with this debilitating condition.
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FDA Grants Accelerated Approval For Targeted Drug for Rare Brain Tumor
FDA Grants Accelerated Approval For Targeted Drug for Rare Brain Tumor
August 7, 2025
Modeyso is the first drug to treat patients with diffuse midline glioma with an H3 K27M mutation, an ultra-rare and aggressive brain tumor.
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Valneva Updates Safety Label of Chikungunya Virus Vaccine
Valneva Updates Safety Label of Chikungunya Virus Vaccine
August 7, 2025
Ixchiq now has a warning about its use among elderly people with multiple underlying health conditions after postmarketing reports indicated there is a risk of neurologic and cardiac events in people over the age of 60.
FDA Approves Presbyopia Treatment, VIZZ
FDA Approves Presbyopia Treatment, VIZZ
FDA Approves Presbyopia Treatment, VIZZ
August 1, 2025
The FDA has approved VIZZ, a once-daily, preservative-free eye drop that improves near vision in adults with presbyopia for up to 10 hours.
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Sarepta to Resume Shipping Elevidys For Ambulatory Duchenne Patients
Sarepta to Resume Shipping Elevidys For Ambulatory Duchenne Patients
July 29, 2025
Sarepta continues to work with regulators to complete the safety label update for Elevidys, and they are discussing an approach for risk mitigation for non-ambulatory patients.
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PBM-Offered Genomics Testing Could Reshape Prescribing of Medications
PBM-Offered Genomics Testing Could Reshape Prescribing of Medications
July 25, 2025
Two PBMs, True Rx Health Strategies and Capital Rx, are using pharmacogenomics — how a person’s DNA affects their response to medications — to reduce the trial-and-error of prescribing medications, saving employers and patients time and money.
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PBM Reform Could Save Almost $100 Billion in U.S. Drug Spending
PBM Reform Could Save Almost $100 Billion in U.S. Drug Spending
July 24, 2025
Health policy researcher Geoffrey Joyce argues that only delinking compensation from the list price of a drug will lower drug spending.
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FDA Extends Review of Blenrep Combinations in Multiple Myeloma
FDA Extends Review of Blenrep Combinations in Multiple Myeloma
July 24, 2025
Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.
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Sarepta to Pause Shipments of the Gene Therapy Elevidys
Sarepta to Pause Shipments of the Gene Therapy Elevidys
July 22, 2025
Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.
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J&J Submits NDA for Icotrokinra, a New Type of Therapy for Plaque Psoriasis
J&J Submits NDA for Icotrokinra, a New Type of Therapy for Plaque Psoriasis
July 21, 2025
Icotrokinra is a first-in-class targeted oral peptide that blocks interleukin (IL) 23 and its receptor, which plays a key role in the inflammatory response in plaque psoriasis.
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FDA Wants Elevidys Off the Market. Sarepta Said No.
FDA Wants Elevidys Off the Market. Sarepta Said No.
July 19, 2025
Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.
Labeling Error Leads Sandoz to Recall the Antibiotic Cefazolin
Labeling Error Leads Sandoz to Recall the Antibiotic Cefazolin
Labeling Error Leads Sandoz to Recall the Antibiotic Cefazolin
July 17, 2025
Some vials in two lots of the antibiotic cefazolin are labeled as being penicillin G potassium, which if used could lead to suboptimal outcomes, adverse events, drug interactions and delayed recovery.
FDA Approves Prefilled Vaccine Presentation for Shingrix
FDA Approves Prefilled Vaccine Presentation for Shingrix
FDA Approves Prefilled Vaccine Presentation for Shingrix
July 17, 2025
This new Shingrix vaccine presentation eliminates the need for reconstitution, simplifying the administration process for healthcare professionals.
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BMS/Pfizer Offer Direct-to-Consumer Option for Eliquis
BMS/Pfizer Offer Direct-to-Consumer Option for Eliquis
July 17, 2025
Following in the footsteps of other pharmaceutical companies, Bristol Myers Squibb and Pfizer are offering Eliquis for cash-paying patients at a discount of 40% off the list price.
New Alopecia Drug Offers Fast Hair Regrowth
New Alopecia Drug Offers Fast Hair Regrowth
New Alopecia Drug Offers Fast Hair Regrowth
July 14, 2025
Leqselvi (deuruxolitinib) 8 mg tablets are approved for adults with severe alopecia areata, a disease that causes the immune system to attack hair follicles, leading to partial or complete hair loss on the scalp and body.
FDA Expands Kerendia’s Use to Treat Common Form of Heart Failure
FDA Expands Kerendia’s Use to Treat Common Form of Heart Failure
FDA Expands Kerendia’s Use to Treat Common Form of Heart Failure
July 14, 2025
Kerendia was originally approved in July 2021 to reduce cardiovascular and kidney complications in patients with chronic kidney disease (CKD) associated with type 2 diabetes. This new approval extends its use to a broader patient population.
FDA Approves Ekterly, First Oral Treatment for Hereditary Angioedema
FDA Approves Ekterly, First Oral Treatment for Hereditary Angioedema
FDA Approves Ekterly, First Oral Treatment for Hereditary Angioedema
July 7, 2025
Orsini will be the specialty pharmacy partner for Ekterly.
Lynozyfic Shows 70% Response Rate in Heavily Pre-Treated Multiple Myeloma Patients, FDA Grants Accelerated Approval
Lynozyfic Shows 70% Response Rate in Heavily Pre-Treated Multiple Myeloma Patients, FDA Grants Accelerated Approval
Lynozyfic Shows 70% Response Rate in Heavily Pre-Treated Multiple Myeloma Patients, FDA Grants Accelerated Approval
July 2, 2025
According to Regeneron, the drug is a bispecific antibody that binds to B-cell maturation antigen (BCMA) on cancerous plasma cells and CD3 on T cells, directing the immune system to attack and destroy multiple myeloma cells.
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