Devices
Smiths Medical is recalling (Class 1) its oral/nasal endotracheal tubes after becoming aware that certain device sizes may have a smaller diameter than represented. “If the diameter of the device is smaller than expected, it may not provide enough ventilation to the patient,” a recall notice says. “The use
Drugs
Cassava Sciences says topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimer’s disease show that the study did not meet each of the prespecified co-primary, secondary and exploratory biomarker endpoints. The co-primary endpoints were the change in cognition and function
Drugs
FDA researchers say most non-oncologic rare disease marketing applications approved between 2020 and 2023 used a single adequate and well-controlled trial plus confirmatory evidence to demonstrate effectiveness. Writing in Clinical Pharmacology and Therapeutics, the researchers say that although different types of confirmatory evidence were used in different applications,
Drugs
FDA has appointed former consultant Barclay Butler as deputy commissioner for operations and chief operating officer. In this capacity, Butler has “leadership authority over the management of business programs and operations across the FDA enterprise level, including human resources and facilities,” according to his just-posted bio. Before joining FDA,
Drugs
Advantage Silver Dental Arrest, Seattle, WA, is petitioning FDA to regulate silver diamine fluoride and silver fluoride agents for dentin hypersensitivity as drugs rather than medical devices and thus rescind premarket clearance of such products. The 3/17 petition says silver diamine fluoride is a liquid drug that is topically
Drugs
Axsome Therapeutics says the FOCUS Phase 3 trial of solriamfetol to treat attention deficit hyperactivity disorder achieved its primary and secondary endpoints, demonstrating statistically significant improvements in symptoms and disease severity with solriamfetol compared to placebo. A company statement says the drug was safe and well tolerated in the trial
Biologics
CBER director Peter Marks says that in an ideal world vaccine clinical trial designs should evaluate the investigational vaccine’s effect on disease transmission. Having such data, particularly if the vaccine has a decent effect against transmission, would be beneficial in today’s age of growing vaccine hesitancy after the
Devices
FDA has granted Powerful Medical a breakthrough device designation for its PMcardio STEMI artificial intelligence (AI) electrocardiogram model for detecting ST-elevation myocardial infarction (STEMI) and STEMI equivalents — described by the company as a life-threatening cardiac condition requiring immediate intervention. The electrocardiogram (ECG) remains the primary tool for rapid
FDA Policy/General
FDA has approved an Alnylam Pharmaceuticals supplemental NDA for Amvuttra (vutrisiran), an RNAi therapeutic for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). Vutrisiran was previously approved for treating polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults. “By rapidly knocking down both mutant and wild‑type transthyretin (TTR), vutrisiran
FDA Policy/General
FDA has approved a Novartis NDA for Fabhalta (iptacopan) for treating adults with C3 glomerulopathy (C3G) to reduce proteinuria. The rare and progressive kidney disease has historically lacked targeted treatment options, and Fabhalta is the first oral inhibitor of the alternative complement pathway, which is believed to drive C3G progression,
Devices
FDA has approved an Abbott IDE for a clinical trial to evaluate its investigational coronary intravascular lithotripsy (IVL) system and its use for treating severe calcification in coronary arteries before stenting, which the company says could offer a new solution for patients with coronary artery disease (CAD). It says CAD
FDA Policy/General
As the Trump Administration is eyeing the closure of 27 FDA field offices across the U.S. under Elon Musk’s Department of Government Efficiency (DOGE) cost-cutting actions (see earlier story), the U.S. Army Corps of Engineers (USACE) just announced the successful completion of a construction project at
Drugs
Tonix Pharmaceuticals says FDA has decided not to require an advisory committee meeting to discuss its recent NDA for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for managing fibromyalgia. If approved, the company says the non-opioid analgesic would be the first new treatment option for fibromyalgia patients in 15
Drugs
FDA has granted Secretome Therapeutics a fast track designation for STM-01, the company’s neonatal cardiac progenitor cell therapy for treating heart failure with preserved ejection fraction (HFpEF). The debilitating condition affects millions of patients worldwide, characterized by impaired heart relaxation and elevated left ventricular filling pressure despite a
Devices
FDA has cleared a Tenon Medical 510(k) for an expanded indication for the Catamaran SI Joint Fusion System for use in augmenting thoracolumbar fusion. With the clearance, the Catamaran is now indicated for treating the SI (sacroiliac) joint as either a stand-alone treatment or to augment spinal fusion.
Devices
Bard Peripheral Vascular is updating the instructions for use (Class 1 recall) for its Rotarex Atherectomy Systems after receiving reports about problems occurring with the helix portion of the device because it rotates at a high rate of speed and may be at risk of fracture or breakage. “Use of
Drugs
As part of the Trump Administration’s regulatory freeze while it reviews pending FDA actions, the effective date of a recent final rule entitled “Nonprescription Drug Product With an Additional Condition for Nonprescription Use (ACNU)” is delayed from 3/21 to 5/27. Previously, the rule was delayed for the
Drugs
Pharmaceutical company HLB and China’s Antengene say FDA has issued a second complete response letter (CRL) on rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment for unresectable or metastatic liver cancer. In May, FDA issued a complete response
FDA Policy/General
Former FDA principal deputy commissioner and second-in-command Namandjé Bumpus has joined the board of Recursion, which is a self-described clinical stage “Tech/Bio” company that looks to decode biology to industrialize drug discovery. Bumpus left the agency 12/31/2024, shortly before the new administration came in.
Biologics
FDA has approved a Johnson & Johnson supplemental BLA for Tremfya (guselkumab) and its use in treating adults with moderately to severely active Crohn’s disease, a chronic gastrointestinal tract disorder. Tremfya is described by the company as the only approved dual-acting monoclonal antibody that blocks interleukin (IL)-23
Devices
FDA has cleared a Vent Creativity 510(k) for its AI-driven software product, Hermes Knee, which uses “deep learning” to generate surgical plans for mechanical, kinematic, and anatomical alignment techniques for total and partial knee arthroplasty procedures. The device is built on the Minerva platform, which allows users to
Drugs
Despite Immunovant promising data from two batoclimab clinical studies for treating myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP), the company says it is delaying its decision on whether to seek FDA approval until the results of ongoing Phase 3 studies in thyroid eye disease are available. Batoclimab is