Shoulder Innovations gets FDA clearance for titanium N-22 Humeral Head
Shoulder Innovations launches the FDA-cleared N-22 titanium humeral head, expanding shoulder replacement options for metal-sensitive patients.
Medical Devices & Diagnostics
Pharma & Biotech
Lundbeck wins FDA Orphan Drug status for asedebart in endogenous Cushing’s syndrome
FDA grants orphan status to Lundbeck’s asedebart for endogenous Cushing’s syndrome as Phase 2 testing examines direct ACTH neutralization.
Features & Analysis
FDA approved Abbott’s dual-energy AFib catheter. Can procedural flexibility beat single-energy simplicity?
Abbott Laboratories has received FDA approval for TactiFlex Duo, a focal ablation catheter capable of delivering both pulsed-field and radiofrequency energy. The system enters a rapidly expanding pulsed-field ablation market with a different proposition: instead of replacing thermal ablation entirely, it lets electrophysiologists choose between energy types during the same procedure.
Features & Analysis
Nanoscope’s MOGENRY does not need to know which RP mutation a patient has. Could that change retinal gene therapy?
Nanoscope Therapeutics has moved MOGENRY into formal FDA review for severe vision loss caused by retinitis pigmentosa. The therapy’s optogenetic strategy is unusual because it attempts to restore light sensitivity in surviving retinal cells regardless of the patient’s underlying mutation, potentially expanding gene therapy beyond one-gene-one-drug models.
Features & Analysis
Continuous glucose monitoring changed diabetes care. Can Nutromics do something similar for hospital drug dosing?
Nutromics has received FDA Breakthrough Device Designation for a wearable patch designed to monitor vancomycin continuously rather than through intermittent laboratory blood draws. Human feasibility data support the concept, but sensor durability, accuracy in critically ill patients and integration into dosing decisions remain the real commercial hurdles.
Features & Analysis
Ionis priced ZANVASTRO at $285,000 a dose. Can the first Alexander disease drug build a viable ultra-rare franchise?
FDA approval has transformed zilganersen from an experimental antisense programme into the first disease-modifying medicine for Alexander disease. For Ionis Pharmaceuticals, however, ZANVASTRO is also a test of whether years of RNA-targeted neurology research can translate into a sustainable independently commercialized franchise.
Pharma & Biotech
Hikma advances specialty nasal spray pipeline with global anaphylaxis filings
Hikma’s epinephrine nasal spray enters regulatory review in the U.S., Europe and UK as competition grows in needle-free anaphylaxis treatment.
Features & Analysis
Scholar Rock has its first FDA-approved drug. How big can ISEMBYLD become alongside existing SMA therapies?
ISEMBYLD is not replacing the therapies that transformed spinal muscular atrophy treatment. Scholar Rock is asking physicians and payers to add a muscle-targeted medicine on top of them, creating a commercial proposition that could expand the market while also making reimbursement and treatment logistics central to adoption.
Features & Analysis
Novartis paid $12bn for Avidity Biosciences. What does del-desiran’s Phase 3 failure do to the deal thesis?
Novartis’ acquisition of Avidity Biosciences brought three late-stage antibody oligonucleotide conjugate programmes into its neuromuscular pipeline. The failure of del-desiran’s Phase 3 HARBOR study now forces investors to separate a damaging lead-asset setback from the value that may remain elsewhere in the platform.
Pharma & Biotech
VOXZOGO added 2.33 cm a year in Phase 3. Can BioMarin turn that growth signal into a new FDA indication?
BioMarin’s VOXZOGO met its Phase 3 hypochondroplasia endpoint with a 2.33 cm/year growth velocity benefit as an FDA filing moves forward.