Relmada Announces FDA Feedback Supporting 2 Separate Acceptable Registrational Study Paths for NDV-01 in Non-muscle Invasive Bladder Cancer

Announces NDV-01 9-Month Follow-up Safety and Efficacy Data in NMIBC FDA feedback supports 2 potential registrational trials – 1) a ...

CervoMed Announces Alignment with FDA on Registration Path for Neflamapimod in Dementia with Lewy Bodies

FDA feedback enables CervoMed to proceed with proposed endpoints, patient enrichment strategy, and other key aspects of Phase 3 trial design to ...

UniQure shares plummet as FDA says inadequate clinical data for Huntington's therapy

UniQure said the U.S. Food and Drug Administration no longer agreed that clinical data for the Dutch company's gene therapy for Huntington's disease may be adequate for a marketing application, ...
Hindustan Times

Lords Mark Industries Ltd.secures US FDA Registration, Reinforces India’s Position in Global Healthcare Manufacturing

Mumbai, October 16, 2025: Lords Mark Industries Ltd., has received US FDA registration for its range of surgical consumables, orthopedic supports, and hygiene products — a milestone that reinforces ...
MedPage Today

FDA Warns on Unauthorized Blood Pressure Measuring Devices

Many blood pressure (BP) measuring devices do not have FDA marketing authorization and can't be relied upon, the agency said in a safety communication. "Do not use unauthorized blood pressure devices, ...
The New York Times

Trump Administration Quietly Seeks to Build National Voter Roll

In a quest to bolster a long-running claim from President Trump concerning undocumented immigrants illegally voting, the Justice Department is seeking detailed voter roll data from over 30 states. By ...
newtelegraphng

Drug Prices Soar As Government Policies Fail

At a time when many Nigerians can barely afford essential medicines, the Pharmaceutical Society of Nigeria (PSN), Lagos State branch, has raised the alarm over the spiraling cost of drugs and the ...
Arizona Mirror

Arizona rejects Trump administration demands for complete voter registration database

Arizona Secretary of State Adrian Fontes says he has refused demands from the U.S. Department of Justice to hand over voter registration information and provide his office’s voter list maintenance ...
Frontiers

Drug lag and associated factors of orphan drugs approved by the U.S. in China

Background: A pronounced disparity exists in the accessibility of orphan drugs between China and developed countries, such as the United States. Identifying and analyzing the critical determinants ...
360dx

AliveDx Nabs FDA Class II Registration for Syndromic Immunoassay Analyzer

NEW YORK – AliveDx said Tuesday that it has registered its multiplex immunoassay analyzer for autoimmune disease and allergy testing with the US Food and Drug Administration as a Class II device that ...
foodengineeringmag

FDA Begins Review Process for ‘Food Chemicals’

The U.S. Food and Drug Administration reports it is launching a systematic review process for “food chemicals,” beginning with certain preservatives and whitening agents. In May, the agency said it ...