Rein Therapeutics has paused patient enrollment and dosing in a mid-stage trial of its lung disease drug in the U.S. after ...

The FDA’s accelerated approval pathway plays a vital role, and scrapping it or reversing course on already-approved therapies ...

But there are limits. Some FDA staff said Elsa often gave wrong answers and has to be double-checked. Others said the tool ...

The U.S. Food and Drug Administration on Thursday approved UroGen Pharma's drug to treat a type of bladder cancer, providing ...

FDA approves new Brukinsa tablet for five blood cancers, offering simpler dosing with the same safety and effectiveness as ...

The U.S. Food and Drug Administration has approved George Medicines' Widaplik (telmisartan, amlodipine, and indapamide) for ...

The Food and Drug Administration has approved a new drug from Merck designed to protect infants from respiratory syncytial ...

The FDA has granted approval to UGN-102 for use in patients with low-grade intermediate-risk non-muscle-invasive bladder ...

UroGen Pharma shares surged after the company received Food and Drug Administration approval for bladder cancer drug Zusduri, previously known as UGN-102. The stock was recently up 36% to $9.96. Prior ...

Some nasal and baby teething swabs from Zicam and Orajel are being recalled across the country because they may be contaminated with fungus, U.S. health officials said.

Federal regulators have launched a comprehensive review of the ingredients in baby formula — the first deep look at the ...