Monthly Prescribing Reference

Monthly Prescribing Reference (MPR) is a digital medical platform and monthly drug reference guide located in New York City.

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Twice-Yearly HIV-1 PrEP Yeztugo Gets FDA Approval

1 week ago | empr.com | Jaymin Kang

The Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35kg who are at risk for HIV-1 acquisition. Yeztugo is an HIV-1 capsid inhibitor with long-acting properties. It is available in both an injectable and tablet formulation. Initiation of Yeztugo involves use of both the tablet and injectable. Continued PrEP involves twice-yearly subcutaneous injections.
FDA Approves Andembry for Prophylactic Use in Hereditary Angioedema

1 week ago | empr.com | Jaymin Kang

The Food and Drug Administration (FDA) has approved Andembry® (garadacimab-gxii) for prophylactic use to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. Garadacimab, an activated Factor XII inhibitor, decreases the activation of prekallikrein to kallikrein and the production of bradykinin, both of which are associated with inflammation and swelling in HAE attacks.
Venetoclax Plus Azacitidine Misses in Treatment-Naïve, Higher-Risk MDS

1 week ago | empr.com | Jaymin Kang

Topline data were announced from a phase 3 trial evaluating venetoclax (Venclexta®) plus azacitidine for patients with previously untreated higher-risk myelodysplastic syndromes (MDS). The randomized, double-blind, phase 3 VERONA trial (ClinicalTrials.gov identifier: NCT04401748) evaluated the safety and efficacy of venetoclax, a B-cell lymphoma-2 inhibitor, with azacitidine, a pyrimidine nucleoside analog of cytidine, in treatment-naïve adults with higher-risk MDS.
Epinephrine Sublingual Film Under Review for Severe Allergic Reactions

1 week ago | empr.com | Jaymin Kang

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for epinephrine sublingual film (Anaphylm™) for the treatment of Type 1 allergic reactions, including anaphylaxis. Epinephrine sublingual film is an investigational polymer matrix-based epinephrine prodrug product.
Steqeyma 45mg/0.5mL Single-Dose Vial Option for Pediatric Use Approved

1 week ago | empr.com | Jaymin Kang

The Food and Drug Administration (FDA) has approved a new presentation of Steqeyma® (ustekinumab-stba), a biosimilar to Stelara® (ustekinumab), for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis or psoriatic arthritis.
Keytruda Gains HNSCC Indication for Perioperative Treatment

2 weeks ago | empr.com | Diana Ernst

The Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab) for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 (PD-L1) (combined positive score [CPS] ≥1) as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
Zusduri Approved for Recurrent Low-Grade Intermediate-Risk NMIBC

2 weeks ago | empr.com | Jaymin Kang

The Food and Drug Administration (FDA) has approved Zusduri (mitomycin intravesical solution) for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC). Zusduri is a sustained-release, hydrogel-based formulation of , an alkylating drug. The treatment is designed to allow the bladder tissue to have longer exposure to the drug.
RFK Jr Selects 8 New Members for CDC’s Vaccine Advisory Panel

2 weeks ago | empr.com | Diana Ernst

The US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr named 8 new members to the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) following the removal of the 17 sitting members this week. The announcement, which was made on X, lists the 8 new members and their credentials. They include Joseph R.
Brukinsa Tablets Get FDA Nod for All Approved Indications

2 weeks ago | empr.com | Jaymin Kang

The Food and Drug Administration (FDA) has approved a new tablet formulation of Brukinsa® (zanubrutinib), which is expected to replace the current capsule formulation in October 2025.
Ibtrozi Approved for Advanced ROS1-Positive NSCLC

2 weeks ago | empr.com | Diana Ernst

The Food and Drug Administration (FDA) has approved Ibtrozi™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib, a tyrosine kinase inhibitor (TKI), is designed to inhibit the growth of cancer cells expressing ROS1 fusion genes and mutations.