FDA: JUUL E-Cigarette Products Banned in US
Individual consumers are not restricted from having or using JUUL products; however, the Agency will ensure compliance by retailers.
All articles by Steve Duffy
Tafinlar-Mekinist Combo Wins Tumor-Agnostic Indication for BRAF V600E Solid Tumors
The accelerated approval was based on data from two phase 2 trials: the ROAR basket study and the NCI-MATCH Subprotocol H study.
FDA Declines EUA Request for Fluvoxamine for COVID-19 Treatment
The totality of the evidence led the FDA to determine that the criteria for issuing an EUA had not been met.
Microbial Contamination Prompts Recall of Suspending Agent Used in Compounding
Hospitals, pharmacies, and distributors are being asked to immediately discontinue use or distribution of the recalled product.
CAR-T Cell Therapy Fast Tracked for B-Cell Non-Hodgkin Lymphoma
A phase 1 trial is currently evaluating the safety and tolerability of ADI-001 in 76 participants with B cell malignancies.
Medtronic’s SCS Therapy Approved for Painful Diabetic Peripheral Neuropathy
These SCS devices were cleared based on data from a randomized controlled trial published in the journal Diabetes Care in 2014.
Weight Loss Medication Wegovy in Short Supply
A contract manufacturer who fills the single-dose prefilled syringe pens has stopped deliveries following issues with Good Manufacturing Practices.
Keytruda Approved for Adjuvant Treatment IIB, IIC Melanoma Following Resection
Approval was based on data from the phase 3 KEYNOTE-716 trial, which enrolled 976 participants.
FDA Clears Add-On Device That Turns MDIs Into Smart Inhalers
The device is attached to the top of the canister of the patient’s inhaler and works together with the mobile app to monitor and provide feedback.
FDA Clears VNS Device for Paroxysmal Hemicrania, Hemicrania Continua
Patients treated with gammaCore experienced clinically meaningful benefits.
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