Devices
FDA has granted Beckman Coulter Diagnostics a breakthrough device designation for its Access p‑Tau217/β-Amyloid 1-42 plasma ratio assay, a blood test to help identify patients with amyloid pathology associated with Alzheimer’s disease. The company says the assay measures the ratio of phosphorylated tau protein (p-
Drugs
FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for treating adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer that has progressed on one or more endocrine therapies. Approval was based on data from the DESTINY-Breast06 Phase 3
Drugs
FDA says a Bioresearch Monitoring Program inspection at a clinical trial site maintained by Dr. Americo Padilla/Miami Dade Medical Research Institute determined that the site did not follow laws and regulations governing the conduct of clinical investigations and the protection of human subjects. A 1/17 Warning Letter says
Biologics
FDA says its review of a Web site maintained by Evolutionary Biologics in New York, NY, and its inspection at Chara Biologics in Chatsworth, CA, determined that the firms are selling unlicensed biologic products that are legally considered to be unapproved new drugs. A just-released 12/30/2024 Warning
Drugs
FDA has accepted for priority review a Merck sNDA for a new indication for its Welireg (belzutifan) to treat adults and pediatric patients over age 12 with advanced pheochromocytoma and paraganglioma. A company statement says the sNDA was based on objective response rate and duration of response data from the
Devices
FDA has cleared an AI Optics 510(k) for its Sentinel Camera, a handheld retinal imaging device for capturing images of the human eye. The AI Optics says the camera is intended for use at point-of-care facilities (general/primary healthcare providers) to eliminate the need for visiting an
Drugs
TerSera Therapeutics is petitioning FDA to require that ANDAs citing the company’s Prialt (ziconotide) as the reference-listed drug/device combination to meet compatibility testing requirements to support product labeling for use with the Medtronic SynchroMed II and SynchroMed III infusion system. The company’s petition says Prialt is
FDA Policy/General
On the eve (1/28) of Robert F. Kennedy Jr.’s confirmation hearing on his nomination to lead the Department of Health and Human Services (HHS), opposition to his potential leadership continued to grow louder and included a scathing letter to U.S. senators from cousin Caroline Kennedy (president John
Devices
FDA has cleared an Imperative Care 510(k) for its Zoom System, a stroke thrombectomy system with .088-inch catheters indicated for both access and aspiration when used with a Zoom Catheter. The clearance expands Imperative Care’s current offering of .035” to .071” aspiration catheters, the company says. The
Drugs
FDA has approved a Supernus Pharmaceuticals label update for attention-deficit/hyperactivity disorder (ADHD) drug Qelbree (viloxazine extended-release capsules) to include new pharmacodynamic data. The updated label (Section 12.2) describes the drug’s “partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter,
Drugs
Provepharm is recalling (Class 1) one lot of phenylephrine hydrochloride injection, USP, 10 mg/mL (pharmacy bulk package) due to a customer complaint about visible black particulate matter found in a single sealed vial. “Administration of an injectable product containing particulate matter may cause local irritation or swelling as a
Drugs
FDA has approved an Eisai/Biogen supplemental BLA for Leqembi (lecanemab-irmb) and its intravenous use once every four weeks as maintenance dosing in Alzheimer’s disease patients with mild cognitive impairment or mild dementia. “After 18 months of once every two weeks initiation phase, a transition to the maintenance
Drugs
Pfizer has agreed to pay $59.7 million to resolve allegations that its subsidiary, Biohaven Pharmaceutical, engaged in illegal kickback schemes before being acquired by Pfizer. The settlement resolves claims that Biohaven provided improper financial incentives to healthcare providers to encourage prescriptions of its migraine drug Nurtec ODT, in violation
Drugs
Vanda Pharmaceuticals has submitted an NDA for tradipitant for treating motion sickness. The submission is based on data from the Phase 3 Motion Serifos study of 316 participants who went on boat trips under varied sea conditions and received tradipitant 170 mg, tradipitant 85 mg, or placebo. “Both 170 mg
Devices
FDA has cleared a ClearPoint Neuro 510(k) for its ClearPoint Navigation Software Version 3.0. The new platform introduces an intraoperative computed tomography (CT)-guided workflow to its existing MRI-guided stereotactic procedures offering, according to the company. “With compatibility for intraoperative CT and Conebeam CT imaging, this enhancement
Drugs
FDA has granted Clarity Pharmaceuticals a fast track designation for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions in patients with biochemical recurrence of prostate cancer following definitive therapy. The designation is based on data the company submitted that
Drugs
Caranx Medical has submitted a PMA for its TAVIpilot AI Software for real-time intra-operative guidance of transcatheter heart valve implantation. The software is designed to assist surgeons in their positioning of a prosthetic heart valve, according to the company. Preoperative CT-scan images are used to plan the
Drugs
ALX Oncology says it plans to discuss with FDA its path for seeking accelerated approval for its investigational CD47-blocker evorpacept based on “positive updated data” from the ASPEN-06 Phase 2 clinical trial demonstrating the therapy generates a durable clinical response with a well-tolerated safety profile among patients
Drugs
FDA has approved a Medexus NDA for Grafapex (treosulfan), an injectable alkylating agent for use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients with acute myeloid leukemia (AML) or myelodysplastic syndrome. Approval was based on data from Phase 3 MC-
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 1/27 to 3/21. The final rule establishes requirements for a
Drugs
CDRH associate director for medical affairs and chief medical officer for in vitro diagnostics Sara Brenner has been elevated to FDA acting commissioner under the Trump Administration. She previously served in the first Trump administration’s White House Office of Science and Technology Policy as a senior policy advisor for
Drugs
Merck and Eisai are announcing disappointing results from the Phase 3 LEAP-015 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), a multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with chemotherapy for the first-line treatment of patients with locally advanced unresectable