FDA approves label change for Depo-Provera, adding brain tumor warning

Pfizer faces a lawsuit in which women allege the drugmaker failed to warn them about the risks of meningioma associated with ...
Medical Device and Diagnostic Industry (MD+DI)

Creating FDA Submissions That Tell A Story

Building FDA submissions like a solid house requires early collaboration, proactive planning, and a clear regulatory story.
Hosted on MSN

FDA Commissioner Makary believes pharmaceutical ads are 'getting out of control'

New FDA Commissioner Dr. Marty Makary touts ongoing efforts by the FDA to crack down on pharmaceutical companies' ability to market directly to consumers. He launched an effort in Sept and s… The ...
Yahoo Finance

Oncolytics Biotech® Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer

SAN DIEGO, November 19, 2025--(BUSINESS WIRE)--Oncolytics Biotech ® Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today announced ...
Food Safety News

FDA tightens import controls on fish, juice, canned foods and more

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed. Recent modifications ...
American Hospital Association

FDA issues most serious recall for certain speed control dials used for wheelchairs

The Food and Drug Administration has identified a Class I recall of Max Mobility/Permobil SpeedControl Dials used with the SmartDrive MX2+ Power Assist Device for wheelchairs after identifying a ...
CNN

FDA official plans to change vaccine approval process, claiming that Covid-19 shots caused child deaths

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. In an ...
Food Engineering

How Food Manufacturers Can Prepare for the FDA’s Synthetic Dye Phase-Out

Compliance will require not only formulation changes but also process redesign, supply chain realignment and organizational ...
FiercePharma

Regeneron wins 2 Eylea nods, ramping up competition with Roche

After months of back-and-and forth with the FDA and a third-party manufacturer, Regeneron has secured two long-awaited approvals for Eylea HD, gaining a new indication and a more flexible dosing ...

Edwards Lifesciences Corporation (EW) Analyst/Investor Day Transcript

INSPIRIS is the leading surgical aortic valve globally around the world. And as mentioned, it has provided extended durability with RESILIA tissue. It is also the only surgical aortic valve with VFit ...
NPR

The CDC revives debunked 'link' between childhood vaccines and autism

The Centers for Disease Control and Prevention has made a dramatic about-face in the agency's position on the relationship between vaccines and autism. The CDC's website now says a link between ...