Casgevy is the first gene therapy approved for sickle cell disease and transfusion-dependent beta-thalassemia in patients aged 2 and older.

When a hospital mistakenly destroyed a patient's placenta despite a signed release form, it faced a lawsuit — and a lesson in what truly constitutes "waste." ...

The products may now carry a claim telling smokers that switching to ZYN "puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis." ...

HbA1c level change from baseline was at least as large with bofanglutide as with semaglutide. HealthDay News — For adults with type 2 diabetes mellitus (T2DM), bofanglutide, a glucagon-like peptide-1 ...

The 12-month wind-down for therapeutics and 180-day transition for medical devices signal a definitive shift back to standard regulatory pathways, forcing manufacturers like Invivyd to pursue full FDA ...

The FDA released a list of participants for a 2-day July meeting of its Pharmacy Compounding Advisory Committee; at least 7 members have ties to peptide businesses.

The chemotherapy-free regimen of Brukinsa and rituximab demonstrated significant progression free survival gains over standard chemoimmunotherapy.

Backed by data from the phase 3 SatraGO trials, satralizumab has the potential to offer patients a convenient, at-home treatment option.

The FDA has approved an expanded indication for Zoryve (roflumilast) cream 0.3% to include plaque psoriasis in pediatric patients aged 2 years and older.

It is increasingly recognized that galactose-deficient IgA in the glomerulus activates the alternative complement system and drives IgA nephropathy, including in the tubules and interstitium, leading ...

Although fasedienol missed its overall phase 3 social anxiety endpoint, the nasal spray showed efficacy in very severe cases in a post-hoc analysis. Topline data were announced from a phase 3 trial ...

RelabotulinumtoxinA is a liquid neuromodulator designed to deliver rapid clinical improvement in glabellar and lateral canthal lines.