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Grace Halsey
Articles
Vertex Nonopioid Analgesic on Par with Placebo in Phase 2 Study of Lumbosacral Radiculopathy
December 19, 2024
Pain relief with suzetrigine was comparable to that seen with placebo, an issue Vertex plans to address with study design as the drug moves to the pivotal phase 3 trials.
Vaccination Information and Educational Resources from the National Foundation for Infectious Diseases
December 19, 2024
Robert Hopkins, Jr, MD, NFID medical director, details a range of resources on the foundation's website including in-depth vaccine recommendations, live webinars, plus much more.
CDC Adds Heplisav-B to Recommendations for HepB Vaccination During Pregnancy
December 18, 2024
The addition, based on an approved update to labeling, expands to 4 the recommended vaccination options that health care professionals can offer to pregnant people.
Sanofi Investigational COVID-19/Influenza Combination Vaccines Granted FDA Fast-Track Designation
December 18, 2024
The 2 novel vaccine candidates each combine a Sanofi licensed influenza vaccine with the Novavax adjuvanted recombinant COVID-19 vaccine.
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.