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 ...
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 ...
MIT Technology Review4d
Here’s what food and drug regulation might look like under the Trump administration
Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and ...
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." ...
The Manila Times46m
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 ...
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 ...
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 Pauses Gilead Trials Testing Experimental HIV Pill Combination
(Reuters) -The U.S. Food and Drug Administration has paused Gilead Sciences' trials testing a combination of two of its experimental HIV treatments due to low levels of a type of white blood cell in ...
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 ...