Autolus Therapeutics Wins FDA Approval for AUCATZYL®
Autolus Therapeutics ( (AUTL) ) has provided an announcement. Autolus Therapeutics has achieved a pivotal milestone with the FDA’s ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
pharmaphorum2d
The evolving role of AI in drug submission and approval: An expert perspective
The integration of AI into drug submission and approval processes signifies a shift towards more efficient pharmaceutical development. The potential benefits are substantial, including faster ...
From AI to Musk’s brain chips, the FDA’s device unit faces rapid change
The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...
Medscape5d
Why a Failed Confirmatory Trial May Not Mean a Failed Drug
there are 64 oncology drug indications on the US market with accelerated approvals only. The FDA estimates the accelerated ...
Crain's Chicago Business5d
Behind burgeoning diabetes treatment, dueling UChicago and UIC profs
At the center of this fight is how the FDA regulates a possible "functional cure" for Type 1 diabetes and determines who gets ...
After decades, FDA finally moves to pull ineffective decongestant off shelves
In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...
News Medical7d
No evidence Trump’s drug program for terminal patients saved ‘thousands’ of lives
Former President Donald Trump has boasted in recent months about "Right To Try," a law he signed in 2018. It's aimed at ...
FierceBiotech8d
FDA delays decision on Merus' first-in-class cancer drug by 3 months
The FDA has scuttled Merus’ plans to win a speedy approval for i | The FDA has scuttled Merus’ plans to win a speedy approval ...
Daily Camera8dOpinion
Guest opinion: Kristina M. L. Acri: Don’t undercut Colorado’s booming tech scene
The U.S. built its thriving tech sector thanks to an effective patent system that rewards bright ideas. Colorado innovators ...
FiercePharma8d
Election spotlight: As Harris and Trump face off, what's at stake for pharma?
Election Day is just about here, marking an end to the unpredictable ride that has been the 2024 presidential race following ...