NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Bioequivalence Determination by Office of Generic Drugs for NRx’s Preservative-Free Ketamine Application

Determination of bioequivalence to the Reference Listed Drug is essential for approval of an Abbreviated New Drug Application (ANDA).FDA has ...
Healio

FDA accepts new drug application for single inhaler triple therapy in asthma

Please provide your email address to receive an email when new articles are posted on . The single inhaler includes an inhaled corticosteroid, a long-acting beta-agonist and an anticholinergic. The ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
JD Supra

Q1/Q2 Sameness: No Longer Just Yes or No for ANDA Applicants

Cathy Burgess, Yifan Wang, Ph.D. A new federal law allows the Food and Drug Administration to provide more detailed feedback earlier in the abbreviated new drug application (ANDA) process, reducing a ...
Precision Medicine Online

Lantheus Gains Tentative FDA Nod for Lutathera Generic Amid Novartis Patent Fight

Last week, the company got the FDA's tentative approval for the radioligand therapy, but a judge may soon decide whether it's ...
Hosted on MSN

Q&A: New drug being reviewed by the FDA to treat Parkinson's disease

The U.S. Food and Drug Administration is reviewing a new Parkinson's disease drug called tavapadon that could give people with the disease more control over their movements. Subscribe to our ...
Cure Today

FDA to Review New Drug Combo for Previously Treated Metastatic Colorectal Cancer

Zanzalintinib plus Tecentriq showed improved survival in metastatic colorectal cancer patients compared to Stivarga in the STELLAR-303 trial. The FDA accepted the new drug application for this ...