News

Aldeyra says FDA accepted resubmitted marketing application for lead drug
Aldeyra Therapeutics (NASDAQ:ALDX) announced on Thursday that the U.S. Food and Drug Administration (FDA) accepted for review ...
Contract Pharma6d
FDA Accepts Biologics License for Proposed Biosimilar to Simponi
The U.S. FDA has accepted a Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab).
Bio-Thera Solutions Announces FDA Accepts Biologics License Application for BAT2506, a Proposed Biosimilar to Simponi®
Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...
BioSpace6d
FDA Layoffs, 200 Rejection Letters, User Fees and Priority Vouchers, Bad Week for Rare Disease
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...
PIRG6d
PIRG to FDA: Engage the public in drug approvals.
The FDA’s mission is to protect public health. PIRG asked: "The prescription drug user fee reauthorization (PDUFA) process starting today must put public health and drug safety at the center of new ...