FDA Related News

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.

Human Drugs

CNS Pharma Orphan Status for Berubicin

FDA grants CNS Pharmaceuticals an orphan drug designation for its lead product berubicin for treating malignant gliomas.

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Federal Register notice: FDA extends until 10/15 the comment period related to a draft guidance for industry #256 entitled Compounding Animal Drugs fr...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