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 ...

Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.

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 ...

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.

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 ...

The CONNEX program consisted of the randomized, double-blind, placebo-controlled phase 3 CONNEX-1, CONNEX-2, and CONNEX-3 studies ...

Mirikizumab is a humanized immunoglobulin G4 monoclonal antibody that selectively binds to the p19 subunit of human interleukin (IL)-23.

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 ...

“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 ...

Moderna’s mRNA-1403 is a messenger RNA-based trivalent vaccine candidate designed to protect against multiple norovirus genotypes. Moderna provided an update on the status of its trial investigating a ...

The Food and Drug Administration (FDA) has revoked the authorization for the use of FD&C Red No. 3 in food and ingested drugs.