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 […]
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 […]
Biden Picks Next CDC Director
On Friday, President Biden announced his intent to choose former top North Carolina health official Mandy Cohen, MD, MPH, to lead the CDC. “Dr. Cohen is one of the nation’s top physicians and health leaders with experience leading large and complex organizations, and a proven track record protecting Americans’ health and safety,” Biden said in […]
Doctors, Nurses Charged in Wide-Ranging COVID Fraud Schemes, DOJ Says
The Department of Justice (DOJ) announced a slew of criminal charges against 18 individuals working in healthcare — including doctors and nurses — for allegedly stealing a total of $490 million in funds from federal health and COVID-related programs. “Today’s announcement marks the largest-ever coordinated law enforcement action in the United States targeting healthcare fraud […]
More Young Kids Can Get Bivalent COVID Booster
More children under age 5 are now eligible for a COVID-19 booster, the FDA announced on Tuesday. Kids ages 6 months to 4 years who completed their primary vaccination with three doses of the monovalent Pfizer-BioNTech shot can now get a booster with the companies’ bivalent COVID vaccine — which targets the Omicron BA.4/5 subvariants […]
What Next After Early End of MOSAICO HIV Vaccine Trial?
SEATTLE — The abrupt and early end of the MOSAICO HIV vaccine trial, announced last month, was the topic of a special session at the Conference on Retroviruses and Opportunistic Infections here. Results of the 3,800-participant trial were negative, with an identical 113 individuals in the vaccine regimen and placebo groups becoming infected with HIV […]
FDA OKs Sparsentan for IgA Nephropathy-Related Proteinuria
The FDA granted accelerated approval to sparsentan (Filspari) for proteinuria in IgA nephropathy, Travere Therapeutics announced, marking the first non-immunosuppressive therapy for this rare condition. Also known as Berger’s disease, proteinuria in IgA nephropathy is the leading cause of kidney failure due to glomerular disease, and sparsentan is specifically indicated to reduce proteinuria in adults […]
Evusheld No Longer Authorized for COVID Prevention
Tixagevimab-cilgavimab (Evusheld) lost authorization for use in the U.S. to prevent COVID-19 until further notice, the FDA announced on Thursday. The agency revised the monoclonal antibody cocktail’s emergency use authorization (EUA) to limit its use to only periods when SARS-CoV-2 variants susceptible to it account for at least 9% of COVID-19 cases nationally. “Data show […]
Jacinda Ardern’s Resignation Is A Lesson For Anyone Who Has Burnout At Work
This week, the Prime Minister of New Zealand, Jacinda Ardern, announced her sudden resignation, saying she no longer had “enough in the tank” to continue leading her country. “I’m leaving because with such a privileged role comes responsibility — the responsibility to know when you are the right person to lead and also when you […]
Advocates Fear The Impact of NYC’s Involuntary Hospitalization Plan
New York City Mayor Eric Adams announced a plan last month to involuntarily hospitalize homeless people with mental illnesses, raising alarm for disability and mental health advocates. Under the new policy, law enforcement, as well as medical workers, will be authorized to remove and involuntarily hospitalize any individual who “appears to be mentally ill” or […]