Flucelvax Quadrivalent

STN: BL 125408Proper Name: Influenza VaccineTradename: Flucelvax QuadrivalentManufacturer: Seqirus, Inc.Indication:Flucelvax Quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus...

REdI Conference 2026 – May 19 and 20, 2026

Save the DateAgenda Coming Soon Register HereVisit CDER Small Business and Industry Assistance (SBIA) HomepageDrugs, Devices, and BiologicsTracks will Offer an Opportunity for 1:1 QuestionsLearn directly from the FDA’s regulatory experts in medical product centers:...

Over-The-Counter (OTC) Heartburn Treatment

What is heartburn? Heartburn occurs when stomach contents flow back up into the esophagus—the muscular tube that carries food and liquids from the mouth to the stomach. Also called acid indigestion, heartburn is an uncomfortable, burning feeling in the mid-chest,...

Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Magnesium Sulfate in Water for Injection, USP 4 g/100mL (NDC 70121-1720-3) Due to a Product Mix-up with Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL

Summary Company Announcement Date: March 24, 2026 FDA Publish Date: March 24, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium...

4U Health – 720527 – 03/17/2026

Delivery Method: Via UPS and EMAIL Reference #: CBER 26-720527 Product: Biologics Recipient: []Recipient Name []Alfred Caminos []Recipient Title []Co-Founder and Managing Director 4U Health []71 Lighthouse Road, Suite 220Hilton Head Island, SC 29928United States...