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

Savara (SVRA) stock in focus as FDA issues a refusal to file letter regarding its marketing application for its lead drug, ...

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

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

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

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.

NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) announced today that the U.S. Food and Drug Administration has accepted for review the Biologics License ...

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

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

The FDA grants RPDD for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the U.S. There are approximately 100,000 people ...

The biotechnology company said the FDA approved the biologics license application for Nuvaxovid to prevent Covid-19 in adults ages 65 and up and individuals ages 12 through 64 who have at least one ...