FDA-cleared OTC glucose sensors have opened continuous monitoring to people who do not use insulin, but evidence for weight loss and broad metabolic improvement in people without diabetes remains limited.
FDA cleared Cubresa BrainPET as a Class II PET-MR imaging system, allowing the removable brain-dedicated PET insert to be used with compatible Siemens infrastructure.
FDA written feedback supports a potential pivotal expansion of REO 033 using response rate and duration as an accelerated-approval strategy, but Oncolytics must first generate supportive randomized Part A data.
FDA has updated TearCare’s indication to state that the system improves meibomian gland function when thermal treatment is combined with manual gland expression.
AbelZeta has regained global rights to dual CD19/CD20 CAR-T prizlon-cel and received FDA IND clearance, backed by early Chinese data reporting a 91.5% response rate.
FDA has approved a single-use LEROCHOL autoinjector and revised the drug’s labeling, with LIB Therapeutics planning US availability by January 2027.
The 85-patient BCI-REHAB study found a 4.5-point treatment difference favoring IpsiHand and a number needed to treat of 2.2, although substantial control-group withdrawal complicates interpretation.
FDA cleared Wellvii BP Go as a Class II non-invasive blood pressure system after published validation found its finger-based measurements met ISO 81060-2:2018 requirements.
Gossamer Bio’s structured financing provides $25 million initially, another $125 million if FDA accepts the seralutinib NDA in 2026 and potentially $100 million more following approval.
Vitruvias Therapeutics is recalling one nationwide lot of 30 mg Thyroid Tablets after testing found potential superpotency, highlighting the narrow dosing margins of thyroid hormone replacement.