First Multiple Sclerosis Biosimilar Approved
The first biosimilar for multiple sclerosis (MS) was approved, the FDA announced late Thursday. Natalizumab-sztn (Tyruko) was approved as a biosimilar to natalizumab (Tysabri) injection to treat clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS, the agency said. Like its reference biologic, natalizumab-sztn (previously called PB006) also was approved to treat certain adult […]
How Far Would the GOP Presidential Candidates Go to End Abortion?
Discussion on abortion is certain to capture voters’ attention at the first Republican primary debate for the 2024 presidential election, to be held in Milwaukee on Wednesday. After the Supreme Court struck down Roe v. Wade last summer, the decision over the legality of abortion was left to states to decide, and conservative-led states rapidly […]
FDA Approves RSV Vaccine For Moms-To-Be To Guard Their Newborns
LOADINGERROR LOADING WASHINGTON (AP) — U.S. regulators on Monday approved the first RSV vaccine for pregnant women so their babies will be born with protection against the scary respiratory infection. RSV is notorious for filling hospitals with wheezing babies every fall and winter. The Food and Drug Administration cleared Pfizer’s maternal vaccination to guard against […]
Ultra-Rare Immune System Disease Gets First FDA-Approved Treatment
The FDA approved pozelimab (Veopoz) as the first treatment for adults and children ages 1 year and up with CD55-deficient protein-losing enteropathy. Also known as CHAPLE (complement hyperactivation, angiopathic thrombosis, and protein-losing enteropathy) disease, CD55-deficient protein-losing enteropathy is an inherited disease marked by mutations of the complement regulator CD55 gene, which causes the complement system […]
FDA Approves Fixed-Dose Prostate Cancer Combination Treatment
The FDA approved the first fixed-dose combination of the PARP inhibitor niraparib and the androgen biosynthesis inhibitor abiraterone (Akeega) for metastatic BRCA-mutant castration-resistant prostate cancer (CRPC). The approval stipulates use of the dual-action tablet with prednisone in patients with metastatic BRCA-mutant CRPC confirmed by an FDA-approved diagnostic test. Eligible patients must have had prior bilateral […]
Laboratory research finds gluten caused brain inflammation in mice
In what is believed to be a world first discovery, University of Otago researchers have found wheat gluten causes brain inflammation in mice. The research, led by Associate Professor Alex Tups, and published in the Journal of Neuroendocrinology, may be of importance for human physiology. “Mice are an excellent model to study human physiology. They […]
FDA OKs First Pill for Postpartum Depression
The FDA approved zuranolone (Zurzuvae) as the first oral treatment for postpartum depression, the agency announced late on Friday. Until now, brexanolone (Zulresso) has been the only other treatment with an indication for postpartum depression, but that drug requires a continuous IV infusion administered by a healthcare provider. “Postpartum depression is a serious and potentially […]
A Game-Changing Pill For Postpartum Depression Was Just Approved By The FDA
Feinstein Institute A photo of zuranolone, the first pill designed to treat postpartum depression, from its phase 3 clinical trial. The Food and Drug Administration on Friday approved the first-ever pill specifically designed to treat postpartum depression. Taken once a day for two weeks, the drug, called zuranolone and marketed as Zurzuvae, can rapidly and […]
Cognitive Dysfunction, Viral Persistence Studied First in New Long COVID Trials
The first two of the long-awaited long COVID clinical trials from the RECOVER initiative are underway, the NIH said. RECOVER-NEURO, which will study interventions for long COVID cognitive dysfunction, and RECOVER-VITAL, a study targeting viral persistence, are opening enrollment, said Acting NIH Director Lawrence Tabak, DDS, PhD, in a press briefing today. Two other trials, […]
First Treatment Approved for Molluscum Contagiosum
Topical cantharidin (Ycanth) was approved as the first treatment specifically for molluscum contagiosum, the FDA announced. Molluscum contagiosum is a viral skin infection that affects as many as 6 million Americans, mostly children. The approval is to treat adults and pediatric patients as young as 2 years. The new treatment consists of a single-use applicator […]