FDA OKs Nitisinone for Ultra-Rare Black Urine Disease
The FDA approved nitisinone (Harliku) for the reduction of urine homogentisic acid (HGA) in adults with alkaptonuria, Cycle Pharmaceuticals announced on Thursday. Alkaptonuria is an ultra-rare hereditary disorder of tyrosine and phenylalanine catabolism, and is commonly known as black urine disease due to the noticeable buildup of HGA. A slow-progressing disease, alkaptonuria can cause tissue […]
Health Insider FDA approves the world’s only twice-a-year shot to prevent HIV AP via Scripps News Group
The U.S. has approved the world’s only twice-a-year shot to prevent HIV, maker Gilead Sciences announced Wednesday. It’s the first step in an anticipated global rollout that could protect millions – although it’s unclear how many in the U.S. and abroad will get access to the powerful new option. While a vaccine to prevent HIV […]
Legislative session focused on PBM reform, behavioral health coverage
Lawmakers approved sweeping changes to pharmacy benefit managers and removed prior authorization for some behavioral health services during the recently concluded spring session. Below is a roundup of some of the proposals that […]
Senate unanimously pass 340B program reforms
Senators unanimously approved a plan Thursday evening to reform Illinois’ 340B program.
Senate approves stricter PBM regulations
Senators approved a plan Thursday night that would reform how pharmacy benefit managers operate in Illinois.
Senate committee approves strengthened shield law for Illinois providers
A Senate committee approved a plan on Wednesday to strengthen protections for providers that offer medication abortion.
Insurance regulations, overdose reporting among proposals passed by Senate committees
Senators approved various healthcare bills ahead of a Friday deadline to advance legislation out of committees.
FDA Approves Nipocalimab for Adult and Pediatric Myasthenia Gravis
The FDA approved nipocalimab (Imaavy) injection to treat adults and children ages 12 and older with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive, Johnson & Johnson announced Wednesday. Nipocalimab is designed to block the immunoglobulin G (IgG) binding site on the neonatal Fc receptor (FcRn) to reduce […]
FDA OKs Injectable Antibiotic for Three Different Uses
The FDA approved the injectable drug ceftobiprole medocaril sodium (Zevtera) to treat adults with Staphylococcus aureus bacteremia (SAB), the agency announced Wednesday. The antibiotic prodrug is indicated for people with right-sided infective endocarditis, those with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients 3 months to less than 18 years […]
Novel Drug Approved for All Duchenne Muscular Dystrophy Variants
The FDA approved oral givinostat (Duvyzat) to treat Duchenne muscular dystrophy (DMD) in patients ages 6 years and older, the agency announced Thursday. Givinostat is a histone deacetylase (HDAC) inhibitor that targets pathogenic processes to reduce inflammation and loss of muscle. It’s the first nonsteroidal drug approved for patients with all genetic variants of DMD, […]