Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT(R) for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)

Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The ...
WESH

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...
Agri-Pulse

FDA looking at animal food ingredient approval process

The Food and Drug Administration is seeking comments on how to handle approval of animal food ingredients following last week’s announcement it will not be renewing a memorandum of understanding with ...
Medscape

FDA Tightens Approval Process for Radiotherapy Devices

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...
WLKY

FDA official plans to change vaccine approval process

A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that COVID-19 vaccination resulted in the deaths of 10 children.Video above: ...
PBS

One medical device is raising questions about FDA’s approval process

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...
Nasdaq

ADMA Biologics Receives FDA Approval for Innovative Yield Enhancement Process, Paving the Way for Increased Production Capacity and Revenue Growth

ADMA Biologics receives FDA approval for a process enhancing plasma production yields by 20%, boosting growth and capacity for its products. ADMA Biologics, Inc. has announced the U.S. FDA approval of ...