May 8th 2024
Data from the ongoing phase 1/2 CHORD trial was presented at the ASGCT annual conference.
Advancing Care in Erosive Esophagitis: Towards a Path of Complete Healing
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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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Patient, Provider & Caregiver Connection™: Implementing an Effective Management Plan to Improve Outcomes in IgA Nephropathy
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Safety and efficacy of FDA-approved linaclotide reinforced with new phase 3 data
January 10th 2024Compared to placebo, linaclotide demonstrated a statistically significant and clinically meaningful improvement in spontaneous bowel movement(s) (SBM) frequency rate, and was subsequently approved by the FDA in June 2023.
FDA accepts sBLA for NexoBrid to remove eschar in pediatric thermal burn patients
January 10th 2024MediWound Ltd is seeking to expand the label for NexoBrid, already approved for eschar removal in adult patients, to the pediatric indication after the FDA accepted a supplemental Biologics Application for this patient population.
Marstacimab reduces annualized bleeding in hemophilia A and B patients
January 8th 2024Marstacimab reduced the annualized bleeding rate (ABR) by 35% and nearly 92%, respectively, compared to routine prophylaxis and on-demand treatment in hemophilia A and B patients without inhibitors, according to Pfizer.
FDA approves prescription berdazimer gel, 10.3% to treat molluscum contagiosum
January 5th 2024Berdazimer gel, 10.3% demonstrated positive, topline data in the phase 3 randomized clinical B-SIMPLE4 trial (NCT04535531) that featured a total of 891 patients aged 6 months or older who had 3 to 709 raised molluscum contagiosum lesions.
Emicizumab-kxwh is effective and safe in treating infants with severe hemophilia A
December 13th 2023New data presented at the American Society of Hematology (ASH) Annual Meeting and Exposition revealed emicizumab-kxwh (Hemlibra; Genentech) controlled bleeding in babies up to 12 months while demonstrating safety and tolerability.
FDA broadens abatacept usage to include psoriatic arthritis patients aged 2 years and older
November 2nd 2023The FDA has approved abatacept (Orencia) for patients aged ≥2 years with active psoriatic arthritis (PsA), a condition causing joint damage in pediatric patients, offering a new treatment option for juvenile PsA, benefiting young patients, caregivers, and healthcare professionals.
Dupilumab demonstrates efficacy in children with eosinophilic esophagitis for up to 1 year
November 1st 2023Longer-term data was recently released for dupilumab as a treatment for eosinophilic esophagitis (EoE) in children aged 1 to 11 years, demonstrating a similar safety and efficacy profile for up to 1 year of treatment. A supplemental Biologic License Application was accepted by the FDA in September 2023 with a Priority Review designation.
Caregiver-administered influenza vaccine’s Biologics License Application accepted by FDA
October 31st 2023A usability study demonstrated that individuals older than 18 years could self-administer the intranasal treatment or administer it to eligible patients aged 2 to 49 years, when given instructions and no additional guidance.
Gene therapy improves auditory response for child with profound genetic hearing loss
October 31st 2023A child with profound genetic hearing loss was dosed with an investigational otoferlin gene therapy (DB-OTO), the first patient dosed in a phase 1/2 trial evaluating the treatment. The child experienced improved auditory response at week 6 with no concerning safety signals.
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.