BioSpace

AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Hosted on MSN

FDA To Streamline Approval Process For Generic Biological Drugs

The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...
JD Supra

FDA Leaders Propose New “Plausible Mechanism Pathway” for Development and Approval of Drugs and Biologics

The Food and Drug Administration (FDA) has issued a statement, published electronically in the New England Journal of Medicine (NEJM) on November 12, 2025, proposing a new process for obtaining ...

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

The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program after agency scientists flagged safety and efficacy concerns, ...
4029tv

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...
NC Biotech

Charlotte’s Milestone Pharmaceuticals gains FDA approval for heart drug

Milestone Pharmaceuticals, a Canadian company with a U.S. subsidiary in Charlotte, is starting the new year with its first ...
STAT

FDA approves first new kind of drug to target gonorrhea in decades

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on ...
Los Angeles Times

Letters to the Editor: What makes drug research so expensive, even before the FDA approval process?

This is read by an automated voice. Please report any issues or inconsistencies here. A rare-disease patient questions what drives research costs behind $41,000-per-month medication, even before FDA ...
The Harvard Crimson

FDA Approves New Drug for Treating Most Common Type of Lung Cancer, Based on Broad Institute Research

The Food and Drug Administration granted accelerated approval on Wednesday for a new drug developed by researchers at the Broad Institute that treats non-small cell lung cancer — the most common type ...