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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Gene Therapy for Hunter Syndrome Under FDA Review

1 day ago | empr.com | Jaymin Kang

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121) for the treatment of mucopolysaccharidosis II (MPS II), also known as Hunter syndrome. MPS II is a rare, X-linked recessive disorder caused by lysosomal iduronate-2-sulfatase (I2S) enzyme deficiency, leading to glycosaminoglycan accumulation and organ dysfunction.
Once-Weekly Somapacitan Noninferior to Daily Somatropin for Pediatric Growth Disorders

2 days ago | empr.com | Jaymin Kang

Topline data were announced from a phase 3 trial evaluating somapacitan in pre-pubertal children with growth disorders. Somapacitan is a human growth hormone analog currently marketed under the brand name Sogroya for the treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH), and for the replacement of endogenous GH in adults with GH deficiency.
FDA Clears Self-Collection Device for Cervical Cancer Screening

5 days ago | empr.com | Jaymin Kang

The Food and Drug Administration (FDA) has approved the Teal Wand™ for cervical cancer screening in women at average risk for the disease, aged 25 to 65 years. The Teal Wand is a prescription, vaginal self-collection device intended to test for 14 types of high-risk human papillomavirus (HPV) that have the highest risk for causing cervical cancer. The device provides an alternative option for women who prefer an at-home method of screening rather than an in-person pap smear.
Icotrokinra Improves Skin Clearance in Scalp, Genital Psoriasis

5 days ago | empr.com | Jaymin Kang

Icotrokinra led to high rates of skin clearance in patients with scalp and genital psoriasis, according to results from the ICONIC-TOTAL study. Icotrokinra is an investigational oral peptide that blocks the interleukin (IL)-23 receptor, which plays a significant role in the pathogenesis of plaque psoriasis and other IL-23 mediated diseases.
MPR Weekly Dose Podcast #236

5 days ago | empr.com | Steve Duffy

New epinephrine nasal spray dosage approved for pediatrics; FDA agree to review semaglutide for weight management; wearable defibrillator cleared to prevent sudden cardiac arrest; a low dose formulation of chlorthalidone is approved to treat hypertension; and Selarsdi is now interchangeable with Stelara.
Avmapki Plus Fakzynja Granted Accelerated Approval for Rare Ovarian Cancer

6 days ago | empr.com | Diana Ernst

The Food and Drug Administration (FDA) has granted accelerated approval to Avmapki™ (avutometinib) plus Fakzynja™ (defactinib) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. Avmapki Fakzynja Co-Pack consists of avutometinib, a rapidly accelerated fibrosarcoma/mitogen-activated protein-kinase kinase clamp, and defactinib, a focal adhesion kinase inhibitor.
Clinical Challenge: Itchy Lesions Affecting Legs, Arms, and Abdomen

1 week ago | empr.com | Stephen Schleicher

Case Study: Explanation: A 41-year-old woman is referred for evaluation of itchy lesions affecting her legs, arms, and abdomen. The condition has been present for several months, and initially responded to hydroxyzine but has now flared. She is on multiple medications and has a history of an anxiety disorder, atrial fibrillation, and hypertension.
Needle-Free Emergency Epinephrine Now Available for Pediatric Patients

1 week ago | empr.com | Diana Ernst

Neffy® (epinephrine nasal spray) 1mg is now available for the emergency treatment of type 1 allergic reactions, including anaphylaxis, in pediatric patients aged 4 years and older weighing 15 to less than 30kg. The 2mg dose was made available previously for patients weighing 30kg or more. Neffy is supplied as a single-dose nasal spray that is administered into 1 nostril.
Neoadjuvant Trastuzumab Deruxtecan Promising in High-Risk, HER2+ Early Breast Cancer

1 week ago | empr.com | Jaymin Kang

Topline data were announced from a phase 3 trial evaluating fam-trastuzumab deruxtecan-nxki followed by paclitaxel, trastuzumab and pertuzumab (THP) in patients with high-risk, locally advanced human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer. Trastuzumab deruxtecan is an HER2-directed antibody and topoisomerase inhibitor conjugate currently approved under the brand name Enhertu® for the treatment of breast cancer, , , and solid tumors.
Narsoplimab Under Review Again for HSCT-Associated Thrombotic Microangiopathy

1 week ago | empr.com | Diana Ernst

The Food and Drug Administration (FDA) has accepted for review the resubmitted Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant (HSCT)-associated thrombotic microangiopathy (TA-TMA). Narsoplimab is a human monoclonal antibody that specifically targets mannan-binding lectin-associated serine protease-2. It is designed to prevent complement-mediated inflammation and endothelial damage observed with TA-TMA.