News

We Spent a Year Investigating How the FDA Let Risky Drugs Into the U.S. Market
Our investigation exposed a little-known practice inside the FDA that allowed more than 150 drugs or their ingredients into ...
PharmaTimes20m
FDA approves UroGen’s Zusduri to treat recurrent bladder cancer
Zusduri, which is delivered directly into the bladder in an out-patient procedure, is now the first and only medication approved by the US regulator to treat adults with recurrent low-grade ...
US FDA extends review of KalVista's swelling disorder drug due to heavy workload
By Puyaan Singh (Reuters) -KalVista Pharmaceuticals' said on Friday that the U.S. Food and Drug Administration had extended ...
The Manila Times17m
Tisento Therapeutics Receives U.S. FDA Fast Track Designation for Zagociguat for the Treatment of MELAS
A first-in-class, brain-penetrant sGC stimulator, zagociguat is hypothesized to rebalance dysregulated cellular pathways in MELAS. By restoring cellular functions that support mitochondria, zagociguat ...
Futurism on MSN3d
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." ...
Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at Increased Risk for RSV Disease
Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS ...
US FDA puts on hold Rein Therapeutics' lung disease drug trial
Rein Therapeutics has paused patient enrollment and dosing in a mid-stage trial of its lung disease drug in the U.S. after ...
US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults
The U.S. Food and Drug Administration on Thursday expanded the use of Moderna's respiratory syncytial virus vaccine to a ...
U.S. News & World Report3d
US FDA Extends Review of KalVista's Swelling Disorder Drug Due to Heavy Workload
US FDA Extends Review of KalVista's Swelling Disorder Drug Due to Heavy Workload By Puyaan Singh (Reuters) -KalVista Pharmaceuticals' said on Friday that the U.S. Food and Drug Administration had ...