The U.S. Food and Drug Administration (FDA) has approved Bayer’s Jivi (BAY94-9027) as a preventive treatment for bleeding in hemophilia A.
A study that examined data from more than 73,000 girls and women shows vaccines designed to prevent infection with human papillomavirus (HPV) are effective in protecting against precancerous cervical lesions in women, particularly in those vaccinated between age 15 and 26 years.
Genentech’s baloxavir marboxil, an experimental, single-dose flu drug, has been given priority review by the U.S. Food and Drug Administration (FDA).
Investigators from the Belgian biotechnology company argenx and U.S. collaborators conducted a PhaseI clinical study to assess a novel modified antibody Fc fragment (efgartigimod) that reduces the circulating IgG level by blocking neonatal Fc receptor-mediated IgG recycling.
The U.S. Food and Drug Administration (FDA) has awarded 12 new clinical trial research grants to principal investigators from academia and industry totaling more than $18 million over the next four years to enhance the development of medical products for patients with rare diseases.
In the largest case series of children with autism spectrum disorder (ASD) treated with IVIG, researchers identified brain-targeted autoantibodies in children with ASD.
The Centers for Medicare and Medicaid Services has revised Chapter 13 of the Medicare Program Integrity Manual to include instructions, policies and procedures that Medicare Administrative Contractors (MACs) use to administer the Medicare fee-for-service program.
The U.S. Court of Appeals for the District of Columbia upheld the reimbursement cut that took effect on Jan. 1 for drugs purchased under the 340B Drug Discount Program reimbursed under the Medicare hospital Outpatient Prospective Payment System (OPPS).
The Centers for Medicare and Medicaid Services (CMS) has issued a final rule that updates the 2019 Medicare payment rates and wage index for hospices servicing Medicare beneficiaries.
The Centers for Medicare and Medicaid Services is launching the Medicare Advantage Qualifying Payment Arrangement Incentive demonstration.
The U.S. Food and Drug Administration (FDA) has approved Shire’s Cinryze (C1 esterase inhibitor [human]) to prevent angioedema attacks in children 6 years and older with hereditary angioedema.
The U.S. Food and Drug Administration (FDA) has approved Incyte Corp.’s Olumiant (baricitinib) 2 mg once-daily oral medication to treat adults with moderately to severe active rheumatoid arthritis.
