As expected, and following impressive phase III data released last September, Ionis Pharmaceuticals Inc. won U.S. FDA approval of Tryngolza (olezarsen) for adults with severe hypertriglyceridemia, unlocking a larger indication and one that held both priority review and breakthrough therapy designations.

When it comes to vaccines and preparedness, platform delivery technologies can be both a boon and a barrier. On the one hand, an existing platform can speed development of a vaccine targeting an unexpected viral scare such as the recent Bundibugyo Ebola and Andes hantavirus outbreaks. On the other hand, the intellectual property (IP) protecting that platform adds to the economic hurdles facing smaller vaccine developers, Douglas Bucklin, a life sciences patent attorney with Volpe Koenig, told BioWorld.

The U.S. FDA approved 24 drugs in May 2026, the busiest month of the year so far. Up from April’s 14, it brings the year-to-date total to 84 approvals. Through May, the agency has cleared 20 new molecular entities, a pace that, if sustained, would put 2026 on track to approach or exceed several recent years.

With increasing competition from China and other countries, the U.S. Department of Health and Human Services is rolling out Operation Trailblazer, a department-wide strategy to once again make the U.S. the go-to destination for early stage drug development.

China’s National Medical Products Administration approved Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid tumors. The autologous Claudin18.2-targeted CAR T was approved for patients with Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy.

Decades of research are helping unravel the “black box” of the brain. The second article in BioWorld’s series on the Brain-Computer Interface (BCI) field looks at how simultaneous breakthroughs in AI technology are pushing the BCI field from a theoretical concept to a potential real-world, clinical option for individuals, particularly in China where the National Medical Products Administration greenlighted the world’s first invasive BCI system – Neuracle Medical Technology Co. Ltd.’s Neural Electronic Opportunity – for clinical use in March 2026.

Anhorn Medicines Co. Ltd. has obtained IND clearance from the FDA for its lead neuroprotective candidate, AH-008, for the prevention of chemotherapy-induced peripheral neuropathy.

Although shot down last year by the U.S. Court of Appeals for the Ninth Circuit, a constitutional challenge to a state law requiring biopharma companies to disclose trade secrets could live to see another court battle.

Prime Medicine Inc. has obtained clearance from the New Zealand authority, Medsafe, for the company’s clinical trial application for PM-577a, an investigational Prime Editor for Wilson’s disease.

Four years after the U.S. FDA issued a complete response letter for Spero Therapeutics Inc.’s oral antibiotic, tebipenem pivoxil hydrobromide, to treat complicated urinary tract infections (cUTI), including pyelonephritis, the agency approved the drug based on phase III data showing noninferiority to intravenous imipenem-cilastatin.