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KalVista Pharmaceuticals Hit by FDA Delays
KalVista Pharmaceuticals faces delays from the U.S. Food and Drug Administration as it looks to get approval for its new drug application for sebetralstat, a treatment for hereditary angioedema.
RECALL: Gummy vitamins sold at BJ’s, ALDI stores recalled due to potential peanut presence
Vitamin gummies sold a BJ’s and ALDI stores nationwide are being recalled due to potential presence of peanuts, according to ...
FDA expands approval of Moderna's RSV vaccine to some adults under age 60
The U.S. Food and Drug Administration expanded its approval of Moderna's respiratory syncytial virus (RSV) vaccine on ...
Precision Medicine Online1h
Syndax Pharmaceuticals Sees Strong Commercial Potential for Newly Approved AML Drug
The drug is already approved for KMT2A-rearranged AML, and Syndax is hoping for approval in NPM1-mutated disease by the end of the year.
NewsNation on MSN1h
FDA approves expanded use of Moderna’s RSV shot
The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include individuals 18 ...
US FDA extends review of KalVista's swelling disorder drug due to heavy workload
The U.S. Food and Drug Administration extended the review of KalVista Pharmaceuticals' drug for a type of hereditary swelling ...
FDA approves expanded use of Moderna’s RSV shot, but uncertainty remains
The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include individuals 18-59 years of age who are at increased risk for severe illness from ...
SeafoodSource4h
US FDA greenlights Wildtype’s cell-cultured salmon as its products hit restaurant menus
The U.S. Food and Drug Administration (FDA) has greenlit sales of Wildtype’s cell-cultured salmon.
FDA approves UroGen’s Zusduri for non-muscle invasive bladder cancer
The Food and Drug Administration said approved UroGen Pharma’s (URGN) Zusduri for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The agency pointed out ...
Futurism7h
The FDA Is Already Outsourcing Drug and Food Analysis to Error-Plagued AI Chatbot
The FDA plans to "unleash AI" on new drug evaluations in order to "radically increase efficiency in the review process." ...