3 There are four categories of drugs available on market without FDA approval: 1. DESI Pending – DESI drugs may stay on the market under current policies. 2. Over the Counter (OTC) Monograph ...

*Includes PARP inhibitors, radionuclides, oncolytic viruses, vaccines, cell-based and novel small molecules.

The EU regulator has approved FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug ... the EMA's CHMP ...

The US Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) 100mg/mL for the treatment of diabetic macular edema (DME), said Swiss pharma giant Roche (ROG: SIX). Roche noted ...

Telethon Foundation’s director general Ilaria Villa said that the foundation is also working on a submission to the US Food and Drug Administration (FDA), to make the therapy ... However, Pfizer ...

Antibody drug developers already routinely include MPA data in regulatory packages, and qualification as a DDT will allow them to further rely on the MPA in the approval process. Integral ...

Italian research charity Telethon Foundation is one step closer to getting a gene therapy to treat rare disease Wiskott-Aldrich syndrome WAS approved ... and Drug Administration (FDA), to make ...

CAICE is a Center for Chemical Innovation focused on the fundamental chemistry behind the impact of aerosol particles on our climate. Research programs focus on marine biomedicine and marine drug ...

The Food and Drug Administration (FDA) recently approved a new targeted chemotherapy drug for adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer.

announced it has received approval for its Phase 2 clinical trial from the European Medicines Agency (EMA). NTRX-07, the Company's lead molecule, will be administered to Alzheimer's disease (AD ...