U.S. FDA approves Amgen's biosimilar version of J&J's psoriasis drug
The U.S. Food and Drug Administration on Tuesday approved Amgen's biosimilar version of Johnson & Johnson's blockbuster psoriasis
2023-11-01 07:30
US FDA staff raise no concerns about Otsuka, Medtronic blood pressure devices
The U.S. Food and Drug Administration (FDA) staff reviewers said on Friday they found no safety and effectiveness
2023-08-19 02:18
US FDA approves Pfizer's blood cancer therapy
(Reuters) -The U.S. Food and Drug Administration on Monday granted accelerated approval to Pfizer's therapy for treating patients with a
2023-08-15 02:19
US FDA approves Johnson & Johnson's blood cancer therapy
(Reuters) -Johnson & Johnson said on Thursday the U.S. Food and Drug Administration had approved its antibody-based therapy for patients
2023-08-10 19:45
U.S. FDA approves Lexicon Pharma's heart failure drug
(Reuters) -The U.S. Food and Drug Administration (FDA) has approved Lexicon Pharmaceuticals Inc's drug as a broad treatment for heart
2023-05-27 04:54
Elon Musk's Neuralink gets US FDA approval for human clinical study of brain implants
Elon Musk's brain-implant company Neuralink on Thursday said it had received U.S. Food and Drug Administration's (FDA) approval
2023-05-26 06:59
U.S. FDA approves Pfizer's COVID antiviral pill
The U.S. Food and Drug Administration on Thursday granted a full approval to Pfizer's Paxlovid, an oral antiviral
2023-05-25 22:26
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
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