FDA Related News

Medical Devices

FDA Grant to Fund Pediatric Device Challenge

An FDA grant and a philanthropic gift from Mei Xu, founder of e-commerce platform Yes She May, will fund a product development competition focused on ...

Biologics

Viela Bio BLA for Optic Rare Disease Approved

FDA approves a Viela Bio BLA for Uplizna (inebilizumab-cdon) injection for intravenous use for treating neuromyelitis optica spectrum disorder.

Biologics

Vaccine Experts Fear Trump Pressure on Covid Tests: CNN

CNN says vaccine experts it interviewed are concerned that the White House will pressure FDA to approve a coronavirus vaccine before it has been adequ...

Human Drugs

5 Companies Recall Some Metformin ER Drugs

FDA identifies five companies that have recalled certain metformin extended-release products following agency testing showing levels of N-Nitrosodimet...

FDA General

Congressional Committees Set Appropriations Mark-Ups

The Alliance for a Stronger FDA says congressional appropriations committees will be marking up bills for the FY 21 appropriations later this month an...

FDA Workload Likely to Increase Post-Pandemic: Officials

CDER and CBER officials tell a BIO digital conference that they are working to cope with pent-up demand and clinical trial issues in a post-Covid worl...

Human Drugs

FDA Approves Tivicay for Infants, Children with HIV

FDA approves Viivs Tivicay and Tivicay PD for treating pediatric patients for HIV-1.

Federal Register

Comments Extended on Animal Bulk Compounding

Federal Register notice: FDA extends until 10/15 the comment period related to a draft guidance for industry #256 entitled Compounding Animal Drugs fr...

Human Drugs

FDA Approves Mylans Semglee Insulin Glargine

FDA approves Mylans Semglee insulin glargine product as a BLA.

Human Drugs

IntelGenx Working on Rizaport NDA Resubmission

IntelGenx says it learned in a 6/10 meeting with FDA officials about the CMC information that is needed in a resubmission of its Rizaport VersaFilm ND...