Savara (NASDAQ:SVRA) announced Tuesday its plans to meet with the U.S. FDA after the regulator issued a refusal to file (RTF) ...

Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active ...

The US Food and Drug Administration (FDA) has accepted Otsuka Pharmaceutical’s biologics licence application for ...

Savara plans to request a Type A meeting with the FDA within the next 30 days. It is currently generating the data requested by the FDA, and expects to resubmit its application in the fourth quarter ...

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgAN) in adults.

The FDA granted rare pediatric disease designation for OCU410ST, a gene therapy designed to treat ABCA4-associated ...

Despite hiring a commercial chief and sponsoring disease awareness efforts last year, Savara will have to wait a while longer ...

OCU410ST has received Rare Pediatric Disease Designation for ABCA4-associated retinopathies, potentially allowing Ocugen to ...

In calling for more clinical testing of vaccines in younger people and those who face a low risk of severe disease from Covid ...

Ocugen ( NASDAQ: OCGN) disclosed on Tuesday that its gene therapy candidate, OCU410ST, has been granted rare pediatric ...

Decision to submit based on a positive overall response rate (ORR) (p-value < 0.0001), one of the dual primary endpoints in the Phase 3 EPCORE ® FL-1 trial Full results from the trial will be ...

“We are pleased with the strength of the data that allows us to submit a supplemental Biologics License Application in accordance with the U.S. FDA’s Project Frontrunner, which supports our ...