Company announcement – No. 51 / 2024 U.S. Food and Drug Administration issues Complete Response Letter for the glepaglutide New Drug Application for the treatment of short bowel syndrome The FDA ...

The U.S. Food and Drug Administration has issued warning letters to four companies — Zest US Wholesale Inc., Xin Ao International Group Corp., Gongora USA Corp., and San Juan Produce LLC — for ...

In a letter to physicians, the company noted that there is an increased risk of blockages in the bloodstream depending on the level of anesthesia for patients undergoing the initial implantation ...

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...

The Food and Drug Administration (FDA) has been busy lately with various recalls. One involved Power Stick deodorant and another involved various ice cream bars across 23 states. Now, a new recall ...

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.

FDA did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimabWALTHAM, Mass., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics ...