Speaking at a Sept. 9 media briefing on the newly released Make America Healthy Again Strategy, U.S. Health and Human Services Secretary Robert Kennedy confirmed what could be the worst fears of many vaccine experts.

The U.S. FDA issued a complete response letter (CRL) for the NDA to privately held Saol Therapeutics Inc.’s rare disease treatment, sodium dichloroacetate (SL-1009), for pyruvate dehydrogenase complex deficiency. The inhibitor of pyruvate dehydrogenase kinases is the only drug in development for treating the rare genetic disorder, according to Cortellis. There are no FDA-approved treatments for the disease.

Neuronos Ltd., a subsidiary of Beyond Air Inc., has announced the granting of orphan drug designation by the FDA to BA-101 for the treatment of glioblastoma (GBM). The company is advancing development of BA-101 toward first-in-human studies.

The U.S. Federal Trade Commission has opened a docket for comment on noncompete employment contracts, a move which suggests that the agency may revert to evaluating these practices on a case-by-case basis rather than by issuing sweeping rules.

The U.S. Office of Inspector General posted an analysis of Medicare spending on skin substitutes, remarking that the data suggest a disproportionate use of these products for patients enrolled in fee-for-service (FFS) care.

Sometimes little things can create big problems, which seems to be the case with the recall of the power unit used with the Abbott Heartmate 3 left ventricular assist device (LVAD). According to the FDA recall announcement, the power cords used with the power supply might not stay fixed in place, which would leave the power supply with 15 minutes of backup battery runtime before depletion.

The U.S. FDA cleared Respiree Pte. Ltd.’s 510(k) for its RS-001 cardio-respiratory wearable that measures respiration and offers passive cardio-respiratory monitoring.

After July’s first-ever release of more than 200 complete response letters (CRLs) by the U.S. FDA, the agency now says it will release letters shortly after sponsors receive them. In addition, the FDA released a new batch of 89 CRLs from 2024 to now that are tied to pending or withdrawn applications.

Biogen Inc.’s IND application for BIIB-142 has been accepted by the FDA. BIIB-142 is a degrader of IRAK-4 that Biogen intends to explore for therapeutic use in patients with autoimmune diseases.

The U.S. Department of Health and Human Services (HHS) reported Sept. 3 that it will engage in “active enforcement” of information blocking rules, each violation of which carries a fine that may reach seven figures.