FDA Related News

Human Drugs

Lilly NDA for Migraine; Plans sBLA for Cluster Headaches

Eli Lilly files an NDA for lasmiditan for the acute treatment of migraine and plans supplemental BLA for cluster headaches.

Human Drugs

California Appeals Court Reverses Drug Preemption Case

A California state appeals court says a lower court must consider new scientific evidence raised by plaintiffs who claim that three drug companies fai...

FDA General

Ultragenyx Pharmaceutical Plans NDA Mid-2019

Ultragenyx Pharmaceutical completes a pre-NDA meeting and plans to submit an NDA for UX007 for treating patients with long-chain fatty acid oxidation ...

Human Drugs

Steps Needed to Speed Biosimilar Market Entry: Study

Harvard Medical School researchers outline several steps that FDA and Congress could take to increase the number of biosimilars available to patients.

Medical Devices

Lumendi 510(k) for Endoscopic Polyp Surgery

FDA clears a Lumendi 510(k) for its DiLumen EIP technology with suture loops placed in the skirt along the trailing edge of the fore balloon, a modifi...

Human Drugs

Ardelyx NDA Accepted for Irritable Bowel Drug

FDA accepts for review an Ardelyx NDA for tenapanor for treating patients with irritable bowel syndrome with constipation.

Medical Devices

Repeat QS Violations in US Vascular Inspection

FDA warns US Vascular about Quality System and Medical Device Reporting violations in its production of VascuLab devices used in vascular pathology.

StemGenex Product Does Not Meet Legal Requirements: FDA

FDA warns StemGenex about multiple violations in its production of a stromal vascular fraction product.

Marketing

FDA to Study Oncology Drug Professional Promotion Disclosures

FDA describes professional promotion research it wants to conduct about oncology drug disclosures.

Drug Recalls Up 19% in 2018 Q3: Stericycle

The Stericycle Recall Index for the third quarter of 2018 shows an increase in drug recalls and a decrease in medical device recalls.