Since 2016, the FDA has received 25 reports of unapproved epinephrine nasal solution being confused with approved epinephrine injection.
Changes to both schedules include new and updated recommendations for COVID-19 vaccine, change to trivalent influenza vaccines ...
The Food and Drug Administration (FDA) has approved Calquence ® (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adults with previously untreated mantle cell ...
Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.
The phase 3 STEP UP trial enrolled 1407 adults aged 18 years and older with a body mass index of at least 30kg/m2 and without diabetes.
Mirikizumab is a humanized immunoglobulin G4 monoclonal antibody that selectively binds to the p19 subunit of human interleukin (IL)-23.
The CONNEX program consisted of the randomized, double-blind, placebo-controlled phase 3 CONNEX-1, CONNEX-2, and CONNEX-3 studies ...
“Taken together, these results indicate that, once PNP or NNP patients develop neuro-PASC, whether they contracted SARS-CoV-2 infection prior to, or after SARS-CoV-2 vaccination makes little ...
RELiZORB is a digestive enzyme cartridge designed to hydrolyze fats contained in enteral formulas, mimicking the function of lipase. The Food and Drug Administration (FDA) has expanded the approval of ...
ONS-5010 is an investigational ophthalmic formulation of bevacizumab, a vascular endothelial growth factor inhibitor, under development as an intravitreal injection.
The Food and Drug Administration (FDA) has revoked the authorization for the use of FD&C Red No. 3 in food and ingested drugs.
The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for subcutaneous (SC) maintenance dosing of lecanemab-irmb for the treatment of Alzheimer disease (AD) in ...