FDA Related News

Human Drugs

FDA Accepts Oyster Point Pharma Dry Eye NDA

FDA accepts an Oyster Point Pharma NDA for its OC-01 nasal spray to treat signs and symptoms of dry eye disease.

Human Drugs

Eyenovia NDA for Pupil Dilation Drug

FDA accepts for review an Eyenovia NDA for MydCombi (tropicamide 1% and phenylephrine 2.5%) ophthalmic solution, a fixed combination mydriatic (pupil ...

Human Drugs

FDA Issues EUA for Janssen Covid Vaccine

FDA issues an emergency use authorization to Janssen Biotech for its single intramuscular Covid-19 vaccine injection.

Medical Devices

Class 1 Recall of Medtronic HVAD Pump Kit

Medtronic conducts a Class 1 recall of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit because the device may fail to initially start,...

Human Drugs

New Rare Disease Efforts to Help Product Development

FDA announces new actions to advance rare disease product development and approval.

Human Drugs

FDA Issues Complete Response on CorMedix DefenCath

FDA sends CorMedix a complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use in kidney failure patients...

Human Drugs

Merck NDA for Cough Drug Accepted for Review

FDA accepts for review a Merck NDA for gefapixant, an investigational selective P2X3 receptor antagonist for treating refractory chronic cough or unex...

Firms Ordered to Pay $834 Million Over Plavix Marketing

A Hawaiian court orders Bristol-Myers Squibb and three U.S.-based Sanofi subsidiaries to pay $834 million to the state of Hawaii over marketing and pr...

Human Drugs

FDA Turns Down Athenex Breast Cancer Drug

FDA sends Athenex a complete response letter on an NDA for oral paclitaxel plus encequidar for treating metastatic breast cancer due to, among other i...

Medical Devices

Empirical Spine PMA for Spinal Tension Band

Empirical Spine says it will submit a rolling PMA for its LimiFlex Paraspinous Tension Band for treating patients suffering from degenerative spondylo...