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Medical Devices

Lunit AI Breast Cancer Detector Cleared

FDA clears a Lunit 510(k) for its Insight MMG, an artificial intelligence application for breast cancer detection.

Medical Devices

Reminder on Leadless Pacing System Complications

FDA says it is working with Medtronic to evaluate outcomes after cardiac perforation following implantation of leadless pacemaker systems.

Human Drugs

FDA Approves New Keytruda Indication

FDA approves a new renal cell carcinoma indication for Mercks Keytruda.

Human Drugs

FDA Says Its Pharmacists Can Help Consumers

FDA says its Division of Drug Information pharmacists are available to answer consumer questions about taking drugs.

Human Drugs

Explore Nitrosamine Impurity Mitigation Strategies: FDA

FDA updates possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products.

Biologics

FDA: We Need 55 Years for Pfizer Vaccine Info Request

FDA tells a Texas federal court it needs until 2076 to respond to a Public Health and Medical Professionals for Transparency request for information o...

Human Drugs

FDA OKs Resumption of Enrollment in Masitinib Trial

FDA says AB Science can resume enrollment of ALS patients in a Phase 3 study of masitinib.

Human Drugs

Fast Track for Zentalis Uterine Carcinoma Drug

FDA grants fast track designation to a Zentalis investigative drug for uterine serous carcinoma.

Human Drugs

Alzheimers Treatment, Diagnostic Registry Launched

The Alzheimers Association and other stakeholders are launching a national registry for Alzheimers diagnostic and treatment information.

Human Drugs

Meeting the 510(j)(3) Reporting Requirement

Two Wiley Rein attorneys suggest ways companies could approach the new FDA section 510(j)(3) drug reporting requirement.