fbpx
March 22, 2021

FDA approves pembrolizumab for esophageal or GEJ carcinoma

On March 22, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy for patients […]
March 22, 2021

Honest Globe, Inc. – 597177 – 03/15/2021

Product: Drugs Recipient: Honest Globe, Inc. 3605 West Macarthur Boulevard, Suite 701Santa Ana, CA 92704-6845United States Issuing Office: Division of Pharmaceutical Quality Operations IV United States […]
March 22, 2021

BioLyte Laboratories, LLC – 603584 – 03/18/2021

Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Kevin J. DeVisser Recipient Title Chief Executive Officer BioLyte Laboratories, LLC 310 Northern Dr. NWGrand Rapids, […]
March 22, 2021

Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea – 04/23/2021 – 04/23/2021

On This Page Date: April 23, 2021 Time: 9:00 AM – 5:00 PM ET DESCRIPTION/SUMMARY This public workshop is currently being scheduled and planned as a […]
March 22, 2021

Sprout Pharmaceuticals, Inc. – 610569 – 03/15/2021

Reference #: NDA 022526 Product: Drugs Recipient: Recipient Name Cindy Eckert Recipient Title Chief Executive Officer Sprout Pharmaceuticals, Inc. 4350 Lassiter at North Hills Avenue, #260Raleigh, […]
March 19, 2021

What It Spells – 30 Seconds – Transcript

MUSIC: IN NARRATOR: Unused prescription opioid pain medicines can spell trouble. They can spell risk if  taken by someone they weren’t prescribed for, harm if accidentally […]
March 19, 2021

Written Requests Issued

Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act NOTE: This list simply identifies […]
March 19, 2021

FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company)

[3/19/2021] FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company), due to microbial contamination risks. The […]
March 19, 2021

Coronavirus (COVID-19) Update: March 19, 2021

For Immediate Release: March 19, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0