By Tom Polansek and Julie Steenhuysen July 14 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it was ...

By Kunal Das and Christy Santhosh July 14 (Reuters) - The U.S. FDA has approved Celcuity's drug for an advanced form of ...

July 10 (Reuters) - The U.S. FDA on Friday proposed a rule to streamline registration requirements for certain drug ...

By Padmanabhan Ananthan June 30 (Reuters) - Unicycive Therapeutics said on Tuesday the U.S. drug regulator has declined to approve its drug to treat elevated phosphate levels in chronic kidney disease ...

The agency is taking action to curb the illicit online trade of unregulated and unapproved ketamine products through a slew ...

The FDA has issued a warning letter to China-based continuous positive airway pressure (CPAP) device maker BMC Medical.

As part of its enforcement activities, the U.S. Food and Drug Administration sends warning letters to entities under its ...

The FDA’s draft MDUFA VI agreement proposes new, faster pre-submission track, changes to de novo communication and more.

The FDA July 10 released a proposed rule that would modernize drug establishment registration requirements, with implications ...

When U.S. health officials meet next month to reconsider a list of controversial peptide drugs, they will hear from a new set of voices: doctors and pharmacists with deep financial ties to the ...

FDA has proposed a rule to streamline registration for certain distributed drug manufacturing sites and ‌clarify reporting ...