The FDA has cleared an IND application for GC-1130A, a treatment for mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome type A) being jointly developed by GC Biopharma Corp. and Novel Pharma Inc.

Ultrasound cyclodestruction may not be the darling of American ophthalmologists and their patients dealing with glaucoma, but that may soon change thanks to a recent move by the U.S. FDA. The agency has down-classified these devices from class III to class II in a move that may prompt competition for current device-based methods of treating glaucoma, including widely used laser-based treatments.

U.S. Medicare coverage of transcatheter aortic valve replacement devices requires the use of team medicine for patient selection purposes, which seems to have served as a tripwire for Cape Cod Hospital (CCH) in Hyannis, Mass. Federal agencies forged an agreement with CCH that included a $24 million fine for failure to appropriately screen patients for the procedure, an event that serves as a reminder that non-compliance with Medicare rules can trigger enforcement actions by other agencies.

The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking.

The U.S. FDA is not the only regulatory agency attempting to deal with impending and existing device and drug shortages, although some of the drivers of these shortages are not within these agencies’ purview.

In April, the U.S. FDA approved 26 new drugs, the sixth-highest monthly total going back to 2016. This is slightly lower than March’s record-setting 30 approvals, the highest count in BioWorld’s records. By comparison, the FDA approved an average of about 16 drugs per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.

The U.S. FDA granted accelerated approval to Amgen Inc.’s Imdelltra (tarlatamab) for treating adults with extensive-stage small-cell lung cancer with disease progression on or after platinum-based chemotherapy. The approval may well lead the drug to blockbuster status while bolstering the company’s cancer portfolio.

Denver-based Arcscan Inc. gained Chinese approval of its computer-controlled, ultra-high frequency ultrasound diagnostic imaging solution for myopia called Insight 100, expanding its reach beyond the U.S. and Europe.

The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking.