FDA will drop two-study requirement for new drug approvals, aiming to speed access

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals ...

NG Biotech announces FDA approval for diagnostic assays

NG Biotech manufactured the assays in France, with Hardy Diagnostics serving as the exclusive distributor in the US.

FDA chief warns US is losing ground to China in early drug development, calls for faster trial approvals

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...
MPR

FDA Approves Wakix for Cataplexy in Pediatric Narcolepsy

New FDA approval for Wakix (pitolisant) allows for the treatment of cataplexy in pediatric narcolepsy patients.

Disc Medicine eyes standard US approval for drug after FDA denies fast-track nod

By Siddhi Mahatole Feb 17 (Reuters) - Disc Medicine said on Tuesday it will pursue a traditional U.S. approval pathway for ...
CURE

FDA Approves Filkri Biosimilar to Prevent Neutropenia in Blood Cancer

The U.S. Food and Drug Administration (FDA) has approved Filkri (filgrastim-laha), a biosimilar to Neupogen (filgrastim), to ...
The American Journal of Managed Care

FDA Approves First-in-Class Optune Pax Device for Pancreatic Cancer

The FDA approved Optune Pax (Novocure), a first-in-class portable device that delivers tumor-treating fields (TTFields) to ...
GlobalData on MSN

Medtronic secures FDA approval for Stealth AXiS spine robotics platform

The Stealth AXiS system architecture allows support for a variety of surgeon preferences and clinical complexities.
Pancreatic Cancer Action Network

FDA Approves New Treatment for Patients with Locally Advanced Pancreatic Cancer: What You Need to Know

Optune Pax® with the chemotherapy combination of gemcitabine and nab-paclitaxel is the first treatment to be FDA approved in nearly 30 years for locally advanced pancreatic cancer.

Phoenix NP Announces Availability of FDA-Approved Zepbound (tirzepatide) Through Its Telehealth Weight Management Program Across Arizona

PHOENIX, AZ - February 02, 2026 - PRESSADVANTAGE - Phoenix NP, a women-focused telehealth medical practice based in ...

Pharma Seeks Relaxed FDA Oversight to Move Drugs to Over Counter

Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to over-the-counter, a rigorous procedure that must demonstrate a patient no longer needs a ...

FDA will drop two-study requirement for new drug approvals

WASHINGTON — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win ...