FDA Related News

Human Drugs

FDA, EMA Parallel Scientific Advice is Effective: Study

FDA and European Medicines Agency staff describe the benefits seen in their joint Parallel Scientific Advice program.

Human Drugs

Lilly Drops Solanezumab on Negative Results

Lilly says it is terminating the clinical development of solanezumab for preclinical Alzheimers disease after it failed to meet the primary or seconda...

How Can FDA Combat Medical Misinformation?

FDA commissioner Robert Califf says in a Stat News interview that FDA is looking for ways to improve and expand its efforts to combat medical misinfor...

FDA Seeks $372 Million (10%) Budget Boost for FY 2024

FDAs seeks a $372 million (10%) boost and a $150 million increase in user fees in its fiscal year 2024 budget proposal.

Human Drugs

AstraZeneca Tagrisso Data on Improved Overall Survival

AstraZeneca says data from its ADAURA Phase 3 trial showed that Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaning...

Medical Devices

Former Stimwave CEO Indicted

The Justice Department says the former CEO of Stimwave has been indicted for healthcare fraud in creating and marketing a non-functional medical devic...

Human Drugs

FDA Approves Amphastar Naloxone Nasal Spray

FDA approves an Amphastar NDA for naloxone nasal spray for emergency treatment of an opioid overdose.

Medical Devices

Shuren Addresses Firms Criticism as Misinformation

CDRH director Jeff Shuren takes the unusual step of addressing a companys criticism directed at his Centers alleged delay in granting an emergency use...

Human Drugs

Determine NMN is a Dietary Supplement: Petition

Two natural product stakeholders petition FDA to determine that nicotinamide mononucleotide can legally be a dietary supplement.

Biologics

Mesoblast Remestemcel-L BLA Resubmitted

FDA accepts a Mesoblast BLA resubmission for remestemcel-L for treating children with steroid-refractory acute graft versus host disease.