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FDA to allow one pivotal trial instead of two for drug approval

Prasad and Makary disagree that some may believe this move shows the FDA relaxing its standards.

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 ...
BioPharma Dive

FDA leaders say one pivotal trial, not two, should be ‘default’ for drug approvals

In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development ...
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.

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 applications process ...

FDA moves to stop non-approved GLP-1 drugs

The U.S. Food and Drug Administration (FDA) plans to take steps to limit the use of GLP-1 in non-FDA-approved compounded ...

U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly ...

Olanzapine long-acting injectable (LAI) suspension (TEV-'749) has the potential to offer the efficacy of olanzapine in a once-monthly, ...

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 ...

Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission

Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics ...

FDA will drop two-study requirement for new drug approvals

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval of new drugs, the agency's leaders said.