Drug Approval

The European Commission has approved Hyqvia as maintenance therapy for individuals of all ages with chronic inflammatory demyelinating polyneuropathy.

Five obesity advocacy organization have issued a joint statement asking the FDA to mandate that all drug approval trials include people with obesity.

LAS VEGAS — The recent FDA approval of Ryzumvi for the reversal of drug-induced mydriasis has created the opportunity to perform more dilated, comprehensive eye exams, according to Paul M. Karpecki, OD, FAAO.

The Lupus Research Alliance, alongside its research affiliate Lupus Therapeutics, have announced the launch of what would be the largest prospective observational study into lupus, as well as a new patient registry and data resource.

The FDA has approved a supplemental new drug application for Rexulti for the treatment of agitation associated with dementia due to Alzheimer’s disease.

The FDA withdrew approval of hydroxyprogesterone caproate injection, the only drug that had been approved to reduce risk for preterm birth in women with a history of spontaneous preterm birth, according to an agency press release.

The Committee for Medicinal Products for Human Use recommended approval of Kapruvia as the first therapy in Europe for chronic kidney disease-associated pruritus in patients on hemodialysis, according to a release.

In October, Boehringer Ingelheim’s adalimumab-adbm secured a landmark FDA approval as the first interchangeable biosimilar to AbbVie’s blockbuster drug, Humira — but, as rivals scramble for second place, will the designation be worth the price?

Unsurprisingly, many of our most-read stories in 2021 were about the COVID-19 pandemic. Stories about COVID-19 vaccines and therapeutics were popular, especially those dealing with approvals, authorizations or recommendations.

The FDA today granted accelerated approval for Aduhelm, the first new treatment to be approved for Alzheimer’s disease since 2003.