FDA Related News

Human Drugs

FDA Accepts Jardiance sNDA for CV Risk Reduction

FDA accepts for priority review a Boehringer Ingelheim and Eli Lilly supplemental NDA for Jardiance (empagliflozin) 10 mg for reducing the risk of car...

Human Drugs

Naviswiss Hip Replacement Navigator Cleared

FDA clears a Naviswiss 510(k) for its Naviplan, a digital pre-operative planning application to assist orthopedic surgeons in performing navigated tot...

Biologics

Novavax Expects U.S. Covid Vaccine Filing Soon

Novavax requests a meeting with FDA in advance of filing for approval of its Covid-19 vaccine.

Human Drugs

PureTech Orphan Status for Pancreatic Cancer Drug

FDA grants PureTech Health an orphan drug designation for LYT-200 and its use in treating pancreatic cancer.

Human Drugs

Topline Data Confirm Semorinemab Effect on Alzheimers

Data presented by Genentech show AC Immunes semorinemab reduced cognitive decline compared to placebo in a Phase 2 Alzheimers disease trial.

Human Drugs

Dont Approve Eagle Vasostrict ANDA Yet: Par

Par asks FDA not to approve an Eagle ANDA referencing Vasostrict until specified changes are made regarding the pH specification.

FDA OKs Resumption of Inovio Covid Vaccine Trial

FDA authorizes Inovio to proceed with the Phase 3 INNOVATE segment of its investigative DNA Covid vaccine clinical trial.

Human Drugs

FDA Clinical Hold on Pfizer Hemophilia A Trial

FDA places a clinical hold on a Pfizer Phase 3 trial of a gene therapy candidate to treat hemophilia A.

Medical Devices

Ellume Covid Test Recall is Class 1: FDA

FDA says the Ellume recall of certain lots of its Covid-19 home test due to an unacceptable level of false-positive results is Class 1.

Medical Devices

HeartVista MRI Software Cleared for Siemens Scanner

FDA clears a HeartVista 510(k) to provide its artificial intelligence-assisted One Click MRI acquisition software on Siemens Healthineers MRI scanners...