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

NRx has received confirmatory FDA minutes from in-person Type C meeting attended by leadership of FDA Division of Psychiatry, FDA Office of ...

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 ...

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 ...

The MarketWatch News Department was not involved in the creation of this content. FORT LEE, N.J., Jan. 30, 2026 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., ...

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 ...

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