Fda

The FDA announced it has commissioned an independent literature review and internal bench laboratory study to evaluate metals in tampons after a recent study suggested tampons sold in the U.S. tested for the presence of toxic metals.

The FDA has granted breakthrough therapy designation to Arrowhead Pharmaceuticals’ plozasiran, coupled with diet, to decrease triglycerides in patients with familial chylomicronemia syndrome, according to a company release.

The FDA has accepted the resubmission of a new drug application for a novel, oral therapeutic intended to treat individuals with acute migraine, according to the manufacturer.

The cosmetic industry is preparing for yet another rapidly approaching deadline imposed by the Modernization of Cosmetics Registration Act of 2022.

The FDA has granted rare pediatric disease designation to Descartes-08, an autologous mRNA cell therapy, for the treatment of juvenile dermatomyositis, Cartesian Therapeutics announced in a press release.

The FDA has granted 510(k) clearance for an insulin patch pump for adults with type 1 or type 2 diabetes, Embecta Corp. announced.

Think Surgical Inc. announced it received FDA 510(k) clearance for its TMINI miniature robotic system to be used with the GMK sphere and SpheriKA knee systems from Medacta, according to a company press release.

Surgical Planning Associates announced it received FDA 510(k) clearance of its HipInsight system 2.0, a mixed reality surgical guidance platform for total hip arthroplasty, according to a company press release.

The FDA granted full approval to Filspari, a daily oral, non-immunosuppressive medication, to slow kidney function decline in adults with primary IgA nephropathy, according to an industry press release.

The FDA has not approved a new sunscreen ingredient since the 1990s, leaving consumers and clinicians wondering why.