fda

Axsome Therapeutics' AXS-05 faces its FDA verdict on April 30 for Alzheimer's disease agitation, backed by four Phase 3 trials but complicated by one failed study.

CorTec's implantable Brain Interchange system received FDA Breakthrough Device Designation on April 8 and TAP acceptance on April 23, marking the first BCI worldwide designated for stroke motor rehabilitation.

The FDA cleared doravirine/islatravir on April 21, completing a development program that was halted in 2021 over lymphocyte counts and restarted at a lower dose.

After FDA 510(k) clearance in December and a 45,000-patient global milestone in March, the Cambridge-based surgical robotics company begins placing its modular, lower-cost Versius Plus system in US hospitals.

Denali's tividenofusp alfa becomes the first FDA-approved biologic engineered to cross the blood-brain barrier, breaking a long rare-disease rejection streak and validating a transport-vehicle platform that could unlock CNS access for many more drugs.

Phase 3 data presented at AAN 2026 show azetukalner nearly halved seizure frequency in treatment-resistant focal epilepsy, with 38% of long-term patients achieving over a year of seizure freedom.

The Dutch medtech giant cleared a 510(k) for a spectral CT that reconstructs 145 images per second using a deep learning engine, bringing always-on spectral imaging to US hospitals for the first time.

Phase 3 RASolute 302 data show the oral RAS inhibitor extending median overall survival to 13.2 months versus 6.7 months on chemotherapy, sending Revolution Medicines shares up nearly 40 percent.

The first once-weekly treatment for achondroplasia is now commercially available in the United States after Ascendis Pharma secured orphan drug exclusivity through 2033.

Prime Medicine is pursuing accelerated approval for PM359, an autologous prime editing therapy that restored immune function in both patients treated for chronic granulomatous disease, marking the first clinical use of prime editing technology.

Samsung has begun a phased rollout of blood pressure monitoring to US Galaxy Watch owners, classifying the feature as a wellness tool under the FDA's updated General Wellness Policy rather than seeking medical device clearance.

United Therapeutics' miroliverELAP, an external bioengineered liver built on a decellularized pig scaffold seeded with human cells, receives FDA RMAT designation after all five Phase 1 patients survived treatment.