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 In addition, the FDA released a new batch of 89 CRLs from 2024 to now that are tied to pending or withdrawn applications.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.

You can’t fault Alcon AG’s focus. In the midst of an extended series of acquisitions, the company has a clear vision of creating a deep ophthalmic treatment pipeline – and diagnostics fall outside that line of sight.

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.

“New explosions in biotechnology are allowing us to interrogate cancers at a very sophisticated level compared to before,” Dennis Slamon told audience members at the Global Bio Conference in Seoul, South Korea Sept. 3.

Propanc Biopharma, Inc. plans to acquire $100 million of Ethereum cryptocurrency over the next 12 months to accelerate its pipeline. The company is advancing its lead candidate, PRP, to enter a phase Ib trial in 30 to 40 advanced cancer patients with malignant solid tumors.