FDA Issues CRL to Dibutepinephrine (Anaphylm) Sublingual Film for Type 1 Allergic Reactions
The CRL cited deficiencies limited to packaging and administration, with resubmission expected as early as Q3 2026.
The CRL cited deficiencies limited to packaging and administration, with resubmission expected as early as Q3 2026.
Investigative topical immunomodulator ILYX-002 has proven its efficacy in treating moderate-to-severe dry eye disease (DED) by achieving its primary endpoint of total conjunctival staining in the recent ILYX-002-201 phase 2 trial.
At the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference in Nashville, Tennessee, the HCPLive editorial team sat down with Tejesh Patel, MD/MBBS, about his portion of the session at RAD titled ‘Dose Flexibility in Adult Atopic Dermatitis.’
“I am reassured by the speed of symptom relief seen in the OAS study and by the continued and consistent rapid absorption profile of Anaphylm,” Jay Lieberman, MD, a professor of medicine in the department of pediatrics at the University of Tennessee Health Science Center, said in a statement. “These data provide strong evidence that… Read More
Incident use of tumor necrosis factor (TNF) inhibitors may be independently associated with an increased risk of progressive kidney function decline in patients with inflammatory bowel disease (IBD), according to findings from a retrospective cohort study published in JAMA Network Open.1
Despite effort and acknowledgement, new research shows kidney transplantation has not improved much in the last 2 decades for patients with end-stage kidney failure (EKSD).
In the US there has been a push to accept more transplant kidneys from hepatitis C viral (HCV) infected donors for hepatitis C negative recipients. A team, led by Miklos Z. Molnar, MD, PhD, Associate Professor of Medicine, University of Tennessee Health Science Center James D. Eason Transplant Institute, examined the association of HCV infected… Read More