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." ...

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

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 ...

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 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." ...

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 total costs of dementia are anticipated to be $818 billion in 2026, driven by quality-of-life losses for persons with dementia and care partners, according ...

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

The expanded indication makes risankizumab the first IL-23 inhibitor available for pediatric patients weighing under 40kg with plaque psoriasis or psoriatic arthritis, supported by phase 3 OptIMMize ...

The letter focuses exclusively on manufacturing control strategies for the biological component and contract manufacturing facility deficiencies. The Food and Drug Administration (FDA) has issued a ...

For ifosfamide, used to treat sarcomas, lymphomas and testicular cancers, some doctors are already meeting to decide who gets treated.

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 ...