As expected, the FDA cleared Biocryst Pharmaceuticals Inc.’s oral, once-daily Orladeyo (berotralstat, formerly known as BCX-7353) for the prevention of hereditary angioedema (HAE) attacks. Last month, Biocryst, as part of its earnings report, said approvals of the compound, a kallikrein inhibitor evaluated by U.S. regulators without an advisory committee meeting, could come in Japan this month and in the EU by the first half of next year.

For the 795,000 Americans who suffer a stroke each year, time is brain. The U.S. FDA granted 510(k) clearance to a solution the developer says could cut time-to-treatment in stroke by an hour, preserving 3.6 years of healthy life. Nico.lab’s artificial intelligence-based CT scan analyzer, Strokeviewer LVO, uses an algorithm that enables faster triaging of stroke patients and enables physicians to see the location of occlusions in minutes.

Recent advances in biomarkers and imaging capabilities have improved the diagnosis of Alzheimer’s disease (AD). Fujirebio Diagnostics Inc. aims to further expand the arsenal of AD diagnostics with its Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test. On Wednesday, the company said it had filed a 510(k) submission with the U.S. FDA for premarket clearance of the Lumipulse G β-Amyloid IVD.

Cerus Corp. has received the green light from the U.S. FDA for its Intercept blood system for cryoprecipitation. The device, which garnered a breakthrough device designation in 2018, is used to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex (PR-Cryo) for treating and controlling bleeding, including massive hemorrhage, associated with fibrinogen deficiency.

Investors in Minerva Neurosciences Inc. on Dec. 1 gave a chilly reception to reported FDA feedback on the company's experimental treatment for the negative symptoms in schizophrenia, roluperidone. Though the drug failed to deliver statistically significant differences vs. placebo in a phase III study this year, CEO Remy Luthringer outlined a potential path to NDA filing for the candidate using a modified intent-to-treat analysis of the trial and evidence from other ongoing evaluations.

The U.S. FDA’s device user fee schedule doubled for both the third and fourth user fee agreements over the prior iterations, but the pressure against another doubling for the fifth iteration of the user fee program is mounting. The Medical Imaging & Technology Alliance (MITA) said it sees a need to retain the user fee programs that are working and to jettison any underperforming programs, adding that user fees “should be stabilized around current funding levels.”