Alzamend Neuro, the Nasdaq-listed clinical-stage biopharmaceutical company, has initiated a Phase II clinical trial of AL001, its ionic cocrystal lithium formulation, in patients diagnosed with bipolar disorder type 1, conducting the study at Massachusetts General Hospital in collaboration with Harvard Medical School investigators. The trial employs a crossover design in which participants receive both AL001 […]
Trividia Health, Inc. has initiated a labeling correction for all TRUE METRIX blood glucose monitoring systems to update how the E-5 error code is described in owner booklets and instructions for use across multiple international markets. The change clarifies that users experiencing symptoms of high blood glucose alongside an E-5 reading must seek immediate medical […]
Rapid Medical disclosed late-breaking results from its DISTALS randomized controlled trial showing that the TIGERTRIEVER 13 thrombectomy device achieved significantly higher tissue reperfusion without symptomatic intracranial hemorrhage compared with medical management in medium vessel occlusion stroke. The data were presented at the 2026 International Stroke Conference and form the basis for a planned United States […]
Johnson & Johnson has presented 12-month pilot data from the OMNY-AF study evaluating the investigational OMNYPULSE Platform for the treatment of symptomatic paroxysmal atrial fibrillation at the 2026 AF Symposium. The early pilot cohort reported high acute procedural success, no procedure-related adverse events, and a 12-month freedom from atrial fibrillation rate approaching 90 percent. The […]
Moderna, Inc. and Merck have reported five-year follow-up results from the Phase 2b KEYNOTE-942 study evaluating intismeran autogene (mRNA-4157 or V940), an investigational individualized mRNA-based neoantigen therapy, in combination with pembrolizumab (KEYTRUDA) in patients with resected high-risk stage III or IV melanoma. The combination demonstrated a 49 percent reduction in the risk of recurrence or […]
Boston Scientific Corporation has announced a definitive agreement to acquire Penumbra, Inc. for approximately $14.5 billion, marking one of its largest acquisitions to date in the medical device sector. The deal, structured as approximately 73 percent cash and 27 percent stock, offers Penumbra shareholders $374 per share and is expected to close in 2026, subject […]
Organon’s etonogestrel implant NEXPLANON has received FDA approval for extended use up to five years, marking a significant regulatory win for the women’s health–focused pharmaceutical company. The decision, which comes via a supplemental new drug application (sNDA), builds on existing data supporting the implant’s high efficacy and safety profile and broadens its potential utility among […]
Camurus AB announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmission of the New Drug Application for Oclaiz (CAM2029), an extended-release octreotide injection for acromegaly. The agency assigned a Prescription Drug User Fee Act (PDUFA) action date of June 10, 2026, reinitiating regulatory review after an earlier Complete Response Letter related […]
GenSight Biologics S.A.’s GS010/LUMEVOQ rollout in France and Israel has done more than expand access—it may be redefining how gene therapies are delivered in ophthalmology. As the company prepares for bilateral administration under early access programs for Leber Hereditary Optic Neuropathy (LHON), it is stepping into a growing shift across the field: a move away […]
The recent U.S. Food and Drug Administration (FDA) approval for RevBio Inc. to begin a pilot trial of its regenerative bone adhesive, TETRANITE, in dental ridge augmentation has reignited industry attention around a long-elusive biomaterials category: viable, clinically integrated bone adhesives. While dental applications are the entry point, the real strategic question is whether these […]
