October 29th 2024
The approval makes methotrexate, currently, the only only oral liquid methotrexate on the market approved for both adult and pediatric indications.
Tackling Inequities in IBD: Inclusive Solutions for Elevated Patient Care
October 26, 2024
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Shaping the Management of COPD with Biologic Therapy
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Elevating Care for PAH: Applying Recommended Management Approaches to Maximize Outcomes
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Clinical Consultations™: Managing Depressive Episodes in Patients with Bipolar Disorder Type II
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Expert Illustrations & Commentaries™: Exploring the Role of Novel Agents for the Management of IgA Nephropathy
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Medical Crossfire®: Understanding the Advances in Bipolar Disease Treatment—A Comprehensive Look at Treatment Selection Strategies
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'REEL’ Time Patient Counseling: The Diagnostic and Treatment Journey for Patients With Bipolar Disorder Type II – From Primary to Specialty Care
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Clinical ShowCase™: Finding the Best Path Forward for Patients with COPD
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A Tethered Approach to Type 2 Diabetes Care – Connecting Insulin Regimens with Digital Technology
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Surv.AI Says™: What Clinicians and Patients Are Saying About Glucose Management in the Technology Age
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Addressing Healthcare Inequities: Tailoring Cancer Screening Plans to Address Inequities in Care
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SimulatED™: Diagnosing and Treating Alzheimer’s Disease in the Modern Era
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Patient, Provider & Caregiver Connection™: Implementing an Effective Management Plan to Improve Outcomes in IgA Nephropathy
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Combination influenza and COVID-19 vaccine program demonstrates positive phase ½ results
October 26th 2023The combination vaccine candidates demonstrated a safety profile consistent with Pfizer’s COVID-19 vaccine. A phase 3 trial is anticipated to commence in the coming months, according to a press release from Pfizer.
IDP-126 topical gel approved by FDA to treat acne in patients 12 years and up
October 21st 2023The topical gel is the first and only FDA-approved triple-combination, fixed-dose topical treatment for acne, and is set to be available in the first quarter of 2024, according to Bausch Health Companies Inc.
Teplizumab effectiveness in adolescents with newly diagnosed type 1 diabetes
October 18th 2023A significant improvement of stimulated C-peptide levels at week 78 for patients newly diagnosed with type 1 diabetes (T1D) was observed for teplizumab-treated patients compared to placebo. Significant differences between groups for insulin dose, percentage of time in target glucose range, and change in glycated hemoglobin were not observed.
Lebrikizumab improves AD symptoms for adolescents inadequately controlled with cyclosporine
October 17th 2023Of the patients that responded to lebrikizumab at week 16 in the phase 3 trials ADvocate 1 and ADvocate 2, 84% achieved a clinically meaningful response in at least 1 domain of the disease (mild signs, symptoms, or quality of life impact) at 52 weeks.
Tapinarof cream 1% reduces itch as early as 24 hours after application for pediatric AD
October 13th 2023A rapid reduction in pruritis as early as 24 hours after first application was announced as new positive data from a pair of identical, phase 3 studies of tapinarof cream 1% in children as young as 2 years and adults with atopic dermatitis (AD).
Crinecerfont safe, effective in treating children with congenital adrenal hyperplasia
October 10th 2023Crinecerfont, an investigational, oral, selective corticotropin-releasing factory type 1 receptor antagonist, achieved the primary and key secondary endpoints in a phase 3 study to treat congenital adrenal hyperplasia due to 21-hydroxylase deficiency in children aged 2 to 17 years.
FDA extends roflumilast cream 0.3% approval to treat plaque psoriasis in children 6 to 11 years
October 9th 2023Once-daily, topical roflumilast cream 0.3% has been approved by the FDA for children aged 6 to 11 years for the treatment of plaque psoriasis based on a data from a 4-week Maximal Usage Systemic Exposure study, and safety and efficacy data from a pair of phase 3 trials in adults.
Nedosiran injection FDA-approved for children with primary hyperoxaluria type 1
October 5th 2023The approval of the prescription injection for children aged 9 years and up is based on data from a phase 2 and an ongoing phase 3 trial extension study, that demonstrated the lowering of urinary oxalate levels for individuals with primary hyperoxaluria type 1 (PH1).
Updated Novavax COVID-19 vaccine authorized for individuals 12 years and up
October 4th 2023Individuals 12 years and older can now receive the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) to protect against variants that are currently circulating, after receiving an Emergency Use Authorization from the FDA.
FDA approves tocilizumab-bavi as biosimilar for PJIA, SJIA in children 2 years and up
October 2nd 2023Tocilizumab-bavi (Tofidence; Biogen) demonstrated a biosimilarity to tocilizumab (Actemra; Genentech) based on multifaceted clinical and non-clinical data for polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (sJIA) in children aged 2 years and up. This makes it the first tocilizumab biosimilar to be FDA-approved in the United States, according to Biogen.
Arcutis submits roflumilast 0.15% sNDA for AD in children 6 years and up
September 21st 2023Positive topline results from a pair of identical phase 3 trials support the submission of a supplemental New Drug Application to the FDA for Arcutis Biotherapeutics’ roflumilast cream 0.15%, a once-daily topical to treat mild to moderate atopic dermatitis (AD) in children 6 years or older.
Roflumilast cream 0.05% safe, effective for children aged 2 to 5 years with atopic dermatitis
September 20th 2023Based on recent positive phase 3 results, Arcutis Biotherapeutics,. intends to submit a supplemental New Drug Application with the FDA for roflumilast cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2 to 5 years.
FDA issues CRL for neffy nasal spray to treat allergic reactions, requests more research
September 20th 2023The FDA issued the Complete Response Letter (CRL) based on the request for a completed pharmacokinetic/pharmacodynamic study to assess how repeat doses of the epinephrine nasal spray compare to repeat doses of an epinephrine injection product. ARS Pharma is set to file a Formal Dispute Resolution Request to appeal the CRL.
FDA approves Pfizer’s maternal vaccine to prevent RSV in infants
August 21st 2023Approved for use at 32 weeks through 36 weeks gestation, Pfizer’s maternal respiratory syncytial vaccine (Abrysvo), is delivered through a single dose injection to the muscle, and is the first vaccine for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD because of RSV in infants (birth to 6 months).
FDA approves pozelimab-bbfg as first CHAPLE disease treatment for children, adults
August 18th 2023Regeneron states all 10 patients achieved normalization of serum albumin and serum IgG concentrations by week 12 in a phase 2/3 trial that investigated the safety and efficacy of pozelimab-bbfg. These concentrations were maintained through 72 weeks.
FDA approves palovarotene capsules to treat fibrodysplasia ossificans progressiva
August 17th 2023Palovarotene is now the first and only treatment for the ultra-rare bone disease fibrodysplasia ossificans progressive (FOP), which impacts approximately 400 people in the United States and 900 globally.
Chikungunya vaccine effective in adolescents after phase 3 trial
August 14th 2023Basis for a Biologics License Application submission to the FDA is being built for PXVX0317, following topline results demonstrated in a pair of phase 3 trials, including 1 trial featuring adolescents and adults aged 12 to 64 years.