Novo’s Awiqli® receives FDA approval as the first and only once-weekly insulin for children 10 years of age and older…

Awiqli® offers children 10 years and older a once-weekly basal insulin alternative, reducing basal injection frequency from seven times per week to…

Ultomiris Wins Accelerated FDA Approval for IgA Nephropathy After Trial Showed 43% Greater Drop in Urine Protein

FDA granted Ultomiris accelerated approval for IgA nephropathy based on lower urine protein. What it means and the infection risks to know.

GSK's hepatitis B drug, Hibsago receives US FDA approval

GSK plc announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB)…

Saluda Medical Reports 28% Revenue Surge to $90.2 Million in FY26, Highlights FDA Approval and Leadership Change -…

FDA Approval Of First Potential Hep B Cure Comes Amid Heated Vaccine Debate

Body: FDA’s approval this week of the first functional cure for hepatitis B was celebrated by the Hepatitis B Foundation as a significant step…

STAT+: GSK picks up hep B drug approval

GSK has won FDA approval for its hepatitis B drug, which extended functional cures to far more patients than previous methods.

Beyond the peptide hype: Which treatments have FDA approval?

Peptides have become a popular topic in the health and wellness world. You may have heard claims that peptide products can help you lose weight…

Merck and Moderna Prepare FDA Filing for Personalized mRNA Melanoma Vaccine Paired with Keytruda After Phase 3 Results

Merck and Moderna are preparing to seek FDA approval for a personalized mRNA melanoma vaccine used with Keytruda. No filing date has been set.

Jemperli Wins Accelerated FDA Approval for a Rectal Cancer Subtype as Most Trial Patients Avoided Surgery

FDA gave Jemperli accelerated approval for dMMR rectal cancer. Most trial patients skipped surgery, but the data are interim. What patients should…

Ryzumvi Eye Drop Wins FDA Approval for Presbyopia, with 27% Reaching the Main Goal in Its Larger Trial

The FDA approved Ryzumvi eye drops for presbyopia in adults. See how the nightly drop works, trial results, side effects, and what remains unknown.

Zilbrysq Autoinjector Wins FDA Approval for Generalized Myasthenia Gravis, but Patients Must Wait Until Early 2027

FDA approved a once-daily Zilbrysq autoinjector for generalized myasthenia gravis. It launches in early 2027 with the same meningococcal infection…