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 […]
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 […]
FDA OKs New Frontline Endometrial Cancer Regimen, First in Decades
The FDA approved the immune checkpoint inhibitor dostarlimab (Jemperli) plus chemotherapy as a frontline option for certain patients with advanced or recurrent endometrial cancer, the agency announced on Monday. For adults with primary advanced or recurrent endometrial cancer that is mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H), dostarlimab is now approved as part of a […]
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 […]
First Dual-Chamber Leadless Pacemaker Approved by FDA
The FDA approved the Aveir DR dual-chamber leadless pacemaker, the first such device to make it to the market, manufacturer Abbott announced. Approved for the treatment of abnormal or slow heart rhythms, the Aveir DR system comprises two small single-chamber pacemakers: the new Aveir AR pacemaker for the right atrium, and the previously approved Aveir […]
FDA Gives Nod to Gene Therapy for Hemophilia A
The FDA approved valoctocogene roxaparvovec (Roctavian) as the first gene therapy for the treatment of adults with severe hemophilia A, drug developer Biomarin announced on Thursday. Patients with severe disease are eligible for the one-time, single-dose treatment if they don’t have antibodies to adeno-associated virus serotype 5 (AAV5), as detected by an FDA-approved test. FDA […]
FDA Greenlights New Myasthenia Gravis Drug
The FDA approved rozanolixizumab-noli (Rystiggo), a neonatal Fc receptor blocker, to treat adults with generalized myasthenia gravis (gMG), UCB announced Tuesday. The drug is the first approved to treat both of the two most common subtypes of gMG patients — those who are anti-acetylcholine receptor (AChR)-positive and those who are anti-muscle-specific tyrosine kinase (MuSK) antibody-positive. […]
First Drug Approved for Kids’ Functional Constipation
The FDA approved linaclotide (Linzess) capsules for treating functional constipation in kids 6 years and up, the agency announced on Monday. Along with data from trials in adults with chronic idiopathic constipation, support for the pediatric approval came from a phase III trial that included 330 children and adolescents ages 6 to 17 years with […]