Jonathan Havens, a former legal counsel at the F.D.A. who now represents companies in the CBD industry, said many growers and manufacturers had grown frustrated with the F.D.A.’s inaction, which…
Tag: FDA
FDA wants to simplify the use and updating of Covid-19 vaccines
CNN — The US Food and Drug Administration wants to simplify the Covid-19 vaccine process to look more like what happens with the flu vaccine, according to documents posted online…
Alzheimer’s drug lecanemab receives accelerated FDA approval amid safety concerns
CNN — The US Food and Drug Administration granted accelerated approval Friday for the Alzheimer’s disease drug lecanemab, one of the first experimental dementia drugs to appear to slow the…
FDA to review preventative option for RSV, developers say
CNN — The US Food and Drug Administration has accepted a biologics license application for a long-acting antibody for the prevention of lower respiratory tract infections caused by the respiratory…
FDA Approves, Leqembi, New Treatment for Early Alzheimer’s
The Food and Drug Administration on Friday approved a new Alzheimer’s drug that may modestly slow the pace of cognitive decline early in the disease, but also carries risks of…
Lecanemab: FDA decision on experimental Alzheimer’s drug expected this week
CNN — The US Food and Drug Administration could decide this week whether to grant accelerated approval to the experimental dementia drug lecanemab, according to Eisai and Biogen, the companies…
FDA Considering New Approach to Blood Donation by Gay and Bisexual Men
The researchers, who enrolled about 1,600 gay and bisexual men in eight metropolitan areas, are hoping to identify a set of screening questions that can differentiate men who are more…
FDA warns against consuming certain raw oysters distributed to 13 states after reported illnesses
CNN — The Food and Drug Administration is advising people in 13 states not to eat certain raw oysters from South Korea after at least one person in Las Vegas…
FDA approves first treatment to delay onset of type 1 diabetes
CNN — A biologic therapy that delays the onset of type 1 diabetes received approval from the US Food and Drug Administration on Thursday. It is the first therapy approved…