Big Pharma wants changes to discount drug program that could expose sensitive medical data

A new policy being pushed by Big Pharma giants could endanger Americans’ medical privacy, opening the door for hackers to ...
RAPS

Study: FDA’s expedited programs play increasing role in bringing novel drugs to market

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...
JD Supra

Rare Disease Focus: FDA’s Trio of Cell and Gene Therapy Draft Guidances Highlight Expedited Programs, Innovative Trial Designs, and Postapproval Evidence Generation

FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are developing and conducting postapproval studies of cell and gene ...
Yahoo

FDA names former pharmaceutical company executive to oversee US drug program

Add Yahoo as a preferred source to see more of our stories on Google. FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, ...
Hosted on MSN

FDA approves multiple breakthrough devices and programs in one week

In a landmark week for medical innovation, the FDA approved or cleared multiple breakthrough technologies, from the first gene therapy for genetic hearing loss to a wireless brain implant trial for ...
JD Supra

New FDA Compliance Program Governs Inspections for CDER-Regulated Biological Products

Cathy Burgess, Yifan Wang, Ph.D. Our FDA: Compliance & Enforcement Team examines a new FDA compliance program for Center for Drug Evaluation and Research (CDER)-regulated biologics, highlighting the ...
MD&M East

FDA Expands Medical Device Recall Alert Program

FDA has expanded its early alert pilot program to cover all medical devices, according to a September 29 notice. In November 2024, the FDA’s Center for Devices and Radiological Health launched the ...
Politico

FDA to seek public input on drug-priority program

THE WEIGHT IS OVER — Danish drugmaker Novo Nordisk won FDA approval Thursday for a higher dose of its weight-loss drug Wegovy — a decision FDA Commissioner Marty Makary touted on social media because ...
Detroit Free Press

FDA-Authorized Expanded Access Programs Utilizing Jaguar Health’s Novel Crofelemer Powder for Oral Solution to Treat Two Pediatric Intestinal Failure Patients with ...

SAN FRANCISCO, CA / ACCESS Newswire / September 30, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is providing the company’s novel ...
Yahoo

Exclusive-US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29 ...
Yahoo Finance

FDA 510(k) Modernization, Breakthrough Device, and Safer Technologies Programs (STeP) Training Webinar

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "510(k) Modernization, Breakthrough Device, and Safer Technologies Programs (STeP) (Oct 8, 2025)" training has been added to ResearchAndMarkets.com's ...