Unlocking future medicines: The crucial role of clinical trials
Regeneron’s clinical trials are at the core of this mission. Regeneron is grateful to all clinical trial participants — ...
Targeted Oncology12h
FDA Approves IND for AS1986NS, a New Approach in Prostate Cancer Research
The FDA has approved the investigational new drug application of AS1986NS for prostate cancer detection and treatment.
FierceBiotech3d
J&J gets FDA thumbs-up to begin clinical trials for its Ottava surgical robot
Johnson & Johnson MedTech has received a go-ahead from the FDA to begin human clinical trials of its Ottava surgical robot, ...
Targeted Oncology1d
FDA Approval Sought for Dato-DXd in EGFR-Mutated NSCLC
A new BLA for datopotamab deruxtecan aims for FDA accelerated approval to treat EGFR-mutated NSCLC based on data from ...
BioPharma Dive4d
FDA lifts pause on Novavax flu vaccine trials
After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
HealthDay on MSN19h
FDA Approves Cobenfy for Adults With Schizophrenia
The U.S. Food and Drug Administration has approved Cobenfy (xanomeline and trospium chloride), a first-in-class muscarinic ...
RFK Jr. Promotes Raw Milk—What Does the FDA Say?
Donald Trump's pick for secretary of the Department of Health and Human Services is a fan of raw milk, despite the FDA saying ...
FierceBiotech2d
FDA hits Kezar's zetomipzomib program with 2nd clinical hold in 2 months
The agency has placed a partial hold on the phase 2a PORTOLA trial evaluating the selective immunoproteasome inhibitor ...
Analysis-RFK Jr vow to purge FDA sets up collision with Big Pharma
WASHINGTON/NEW YORK (Reuters) - Robert F. Kennedy Jr. vowed to purge the U.S. Food and Drug Administration shortly before ...
JD Supra1d
FDA Advisory Committee outlines informed consent best practices
The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed ...
FDA moves to pull popular decongestant from shelves amid effectiveness concerns
The FDA announced a proposal to remove oral phenylephrine – a common ingredient in many popular over-the-counter ...