FDA approves Emrosi for rosacea in adults
The U.S. Food and Drug Administration has approved Journey Medical's Emrosi (minocycline hydrochloride) for the treatment of ...
JD Supra21h
How the US Election May Affect the FDA Regulation of Life Sciences Products – Key Areas to Watch
The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, ...
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, ...
MedPage Today1d
FDA Rejects Full Approval of Liver Disease Drug
Notably, the FDA this year granted accelerated approval to two other drugs -- seladelpar (Livdelzi) and elafibranor (Iqirvo)- ...
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 ...
Unicycive: FDA to Review Lead Drug Candidate for Hyperphosphatemia
Unicycive, which is seeking an FDA green light for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis, Monday said the agency set a target ...
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 ...