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.

Following a May phase II readout and a recent presentation of Tourmaline Bio Inc.’s long-acting anti-IL-6 IgG2 monoclonal antibody, pacibekitug, for atherosclerotic cardiovascular disease (ASCVD), Novartis AG offered $1.4 billion, or $48 per share, to buy the barely 4-year-old company. Previously shelved by Pfizer Inc., which had been developing it for autoimmune disorders, pacibekitug fell into the hands of New York-based Tourmaline through a May 2022 license agreement. In addition to the Tranquility phase II trial in ASCVD, the company’s lead product is also in the phase IIb Spirited trial for thyroid eye disease, a readout for which is expected in early 2026.

Heartbeam Inc.'s algorithms performed as well on a standard 12-lead electrocardiography (ECG) as on its 3D ECG system in the detection of atrial fibrillation, atrial flutter and sinus rhythm, based on a study presented by Joshua Lampert, cardiac electrophysiologist and medical director of machine learning at HRX Live 2025 in Atlanta.

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.

Robust efficacy, competitive tolerability and ease of administration. Those are the qualities for a potential blockbuster antiseizure medication, according to Abe Ceesay, CEO of Rapport Therapeutics Inc., which reported a successful phase IIa trial testing RAP-219 in patients with drug-resistant focal onset seizures and aims to move into a large-scale phase III program in 2026.

Edwards Lifesciences Corp. fully acquired Vectorious Medical Technologies Ltd. for $497 million, following a series of investments in the heart failure technology company over the last five years.

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.

The BioWorld Neurological Diseases Index showed signs of recovery in August, narrowing its year-to-date decline to 14.31%, compared to a steeper drop of 22.34% at the end of May. Momentum shifted notably over the summer, with 17 of the 20 component companies posting gains between June and August. This marks a reversal from May, when 15 of the 20 stocks were in the red.