Ocugen Inc. has received IND clearance from the FDA for OCU-500, an inhaled mucosal vaccine for COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID) will sponsor and conduct a phase I trial of OCU-500 administered via inhalation into the lungs and intranasally as a spray.

A U.S. Federal Claims Court judge shot down Vanda Pharmaceuticals Inc.’s accusations that the FDA disclosed the company’s trade secrets to generic competitors, finding that the trade secrets weren’t really secret or necessarily proprietary to Vanda.

A pair of investor calls on Jan. 22 added clarity to the rapidly evolving cardiac ablation market with Abbott Laboratories and Johnson & Johnson providing updates on their pulsed field ablation programs. Both outlined challenges in the U.S. market that continue to place them at a disadvantage compared to current market leaders Boston Scientific Corp. and Medtronic plc, though bright spots also shone through.

The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted Jan. 14, and dated between Dec. 6 and Dec. 19, 2024, but otherwise seem to have little in common.

South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.

The U.S. FDA approved 19 drugs in December, an increase from 10 in November. In total, 228 FDA approvals were granted in 2024, averaging 19 per month. Seven new molecular entities were approved in December, bringing the year's total to 49.

With key officials yet to be confirmed at the U.S. Department of Health and Human Services, the acting secretary imposed an immediate pause throughout the department on publicly issuing any document or communication without first getting it approved by a presidential appointee.

The backlog of requests for Medicare national coverage analyses is a matter of record, but a new analysis highlights how deep that backlog runs. CMS declared it will review a petition from Impulse Dynamics to consider coverage of cardiac contractility modulation, responding to a request the company filed more than two and a half years ago.

Tikun Therapeutics Inc. has obtained U.S. orphan drug and rare pediatric disease designations for its programs in familial dysautonomia, namely its rAAV2-U1a-hELP1 gene replacement therapy for the treatment of optic neuropathy in familial dysautonomia and BPN-36964 for systemic treatment of familial dysautonomia.

Medexus Pharmaceuticals Inc. looks set for its U.S. launch of bifunctional alkylating agent treosulfan in the first half of 2025 following a long-awaited FDA approval of the drug, branded Grafapex, for use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adults and pediatric patients, 1 and older, with acute myeloid leukemia or myelodysplastic syndrome.