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Grace Halsey
Articles
A Vaccination Imperative: "Please, Let's Do It," NFID Medical Director Robert Hopkins, Jr, MD, Urges
December 18, 2024
The National Foundation for Infectious Diseases medical director appeals to the community at large to set politics and personal grievance aside and to "first, do no harm."
10 Essential Vaccine Updates for Primary Care
December 17, 2024
From ACIP updates on age eligibility and research on vaccine efficacy to US adults' attitudes toward recommended shots, these 10 at-a-glance news briefs are must-reads for PCPs.
FDA Accepts NDA for TNX-102 SL, Tonix Nonopioid Analgesic for Fibromyalgia
December 17, 2024
If approved, the nonopioid, centrally acting analgesic would be the first in a new class of medications for fibromyalgia in more than 15 years, Tonix said.
Expert Perspectives 2024: Breakthrough Therapy for Congenital Adrenal Hyperplasia with PI Richard Auchus, MD, PhD
December 17, 2024
The lead investigator of the largest clinical trial program in people with CAH discusses the condition, its burden, and the novel drug just approved that will change lives.
FDA Accepts Merck's BLA for Clesrovimab, an Investigational mAb Against RSV in Infants
December 17, 2024
Clesrovimab, if approved, would be the only immunization for both healthy and at risk infants using the same dose. FDA set A PDUFA date of June 2025.
FDA Receives sNDA for Roflumilast Cream 0.05% to Treat Atopic Dermatitis in Children Aged 2 to 5 Years
December 16, 2024
Arcutis Biotherapeutics announced submission of the sNDA today, citing the the supporting positive data from the phase 3 INTEGUMENT-PED and INTEGUMENT-OLE trials.
Tapinarof Cream, 1%, Gets FDA Green Light for Atopic Dermatitis in Individuals Aged 2 Years and Older
December 16, 2024
Approval for the topical nonsteroidal therapy, based on data from the phase 3 ADORING clinical trial program, helps fill a gap in current offerings for atopic dermatitis.
Richard J Auchus, MD, PhD, Details Pivotal Phase 3 Trial That Supported FDA Approval of Crinecerfont for Congenital Adrenal Hyperplasia
December 16, 2024
Auchus details findings from the unique study of the CRF-1 antagonist crinecerfont, the first new therapy for CAH approved in 70 years.
FDA Approves Crinecerfont for Congenital Adrenal Hyperplasia in Adults and Children in Landmark Decision
December 14, 2024
Crinecerfont approval makes available the first new treatment for the life-altering endocrine disorder in more than 70 years, according to Neurocrine Biosciences.
Expert Perspectives 2024: Nonsteroidal Topicals for Atopic Dermatitis with Mona Shahriari, MD
December 12, 2024
The new nonsteroidal topical treatments for atopic dermatitis are targeted and modify the disease process, explains thought leader Shahriari in this year's video series.