Aescuvest Capital Partners (ACP) is at the forefront of Healthtech investing, leveraging its deep expertise in European ...

Big developments are expected this week at the 2025 ASCO Gastrointestinal Cancers Symposium, running January 23-25 in San Francisco. This year's event is particularly critical as researchers highlight ...

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.

Not all chemical hair relaxers include the chemical, but many include ingredients that can release formaldehyde when heated, the FDA said in 2024. Over the years, an increasing number of studies ...

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 ...

A government watchdog examining the FDA’s accelerated approval pathway has released a 32-page report (PDF) that concludes the agency’s controversial endorsement of Biogen’s failed Alzheimer ...

The treatment was approved in 2024 for chronic graft-vs-host disease after failure of at least 2 prior lines of systemic therapy in patients weighing at least 40kg. The Food and Drug ...