US FDA approves Genmab-AbbVie's blood cancer therapy
(Reuters) -The U.S. Food and Drug Administration has approved AbbVie Inc and Danish drugmaker Genmab's blood cancer therapy for adult
2023-05-20 01:55
Pfizer's maternal RSV vaccine effective at preventing severe infections in newborns, FDA says but flags potential risk of preterm birth
Pfizer's vaccine to protect newborns from respiratory syncytial virus, or RSV, by vaccinating their moms late in pregnancy cuts the risk that infants will need to see a doctor or be admitted to the hospital with a moderate to severe infection before 6 months of age, according to a new analysis by government regulators.
2023-05-17 02:52
FDA green lights a new type of drug for menopausal hot flashes
The US Food and Drug Administration on Friday approved a new type of drug to treat hot flashes and night sweats during menopause.
2023-05-13 04:55
Families facing rare muscle disease are pushing for an experimental gene therapy, but the FDA is skeptical
SRP-9001, an experimental gene therapy that aims to slow or stop the progression of Duchenne muscular dystrophy, is being considered for accelerated approval by the FDA.
2023-05-12 22:27
U.S. FDA advisers back Perrigo birth control pill for over-the-counter use
By Sriparna Roy and Nandhini Srinivasan (Reuters) -A U.S. Food and Drug Administration advisory panel on Wednesday voted in favor
2023-05-11 12:50
FDA advisers vote unanimously in support of over-the-counter birth-control pill
Advisers for the US Food and Drug Administration voted unanimously on Wednesday in support of making a birth control pill named Opill available over-the-counter, saying the benefits outweigh the risks.
2023-05-11 01:47
As FDA advisers consider OTC birth-control pill, agency scientists worry it won't work due to women's weight and likelihood of following label
On Tuesday and Wednesday, a group of external advisers to the US Food and Drug Administration will discuss an application from a pharmaceutical company to put their prescription birth control pill over-the-counter.
2023-05-09 19:54