Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License Application, sBLA, for once every four weeks lecanemab ...

Eisai has submitted applications for approval of lecanemab in 17 countries and regions. Additionally, the FDA accepted Eisai's Supplemental Biologics License (BLA) for the LEQEMBI subcutaneous ...

Brenner replaces Dr. Robert Califf. The announcement was made quietly via an update made online to the FDA’s leadership bio page. As of Jan. 24 Brenner’s biography had not been added to the page.

The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Use the chart below to view import alerts.

News-Medical speaks with Jordi Labs’ about its recent achievements, alignment with FDA expectations, and strategic ...

GRAFAPEX™ (treosulfan) with fludarabine is FDA-approved for AML and MDS patients undergoing alloHSCT, showing improved overall survival compared to busulfan. Common side effects include ...

Jan 27 (Reuters) - The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai (4523.T), opens new tab and partner Biogen's (BIIB.O), opens new tab Alzheimer's ...

Since the Supreme Court’s Dobbs ruling overturned Roe v. Wade in 2022, Republicans have challenged the FDA’s decadeslong approval of mifepristone as a safe and effective medication for abortion.

Algeness ® is the culmination of many years of scientific and clinical research to define a novel biocompatible material to ...

RFK Jr grilled on vaccines and abortion rights during tense confirmation hearing - Robert F Kennedy Jr quizzed by Senate ...

The move comes 35 years after the FDA banned the dye in cosmetics like lipstick, and two years after a petition led by the Center for Science in the Public Interest showed that the additive, in high ...