RAPS

FDA finalizes COVID-era guidance on container closure changes

The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors in reporting common changes made to glass vials and stoppers, called container closure systems (CCS), used to hold ...
Benzinga.com

FDA Removes Partial Hold On Zentalis Pharmaceuticals' Azenosertib Studies In Patients With Gynecological Cancers

Zentalis will be working with clinical trial investigators to resume study activities across the azenosertib development program. Zentalis remains on track to meet all previously disclosed data ...
Seeking Alpha

FDA Lifts Partial Clinical Hold on Tradipitant for Motion Sickness

WASHINGTON, Dec. 4, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (VNDA) today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on protocol ...
Hosted on MSN

MacroGenics gains removal of FDA partial hold on lead program

Macrogenics (MGNX) shares traded higher in the premarket on Thursday after the U.S. Food and Drug Administration (FDA) removed a partial clinical hold imposed on a mid-stage trial for its lead ...
RAPS

COVID-19: FDA offers guidance on container closure switches

The COVID-19 pandemic has created unprecedented global demand for raw materials and components of products used in the response to the virus. Supply chains for critical materials such as reagents, ...
Nasdaq

FDA Removes Partial Clinical Hold On Tradipitant For Motion Sickness

(RTTNews) - Vanda Pharmaceuticals Inc. (VNDA) announced on Thursday that the U.S. FDA has lifted the partial clinical hold on its motion sickness protocol, VP-VLY-686-3403, for Tradipitant, which had ...