Shares of Candel Therapeutics, Inc. (CADL) traded 8% higher on Wednesday morning after the U.S. Food and Drug Administration ...

Candel Therapeutics stock rose after its prostate cancer therapy, CAN-2409, received FDA RMAT designation. This expedites ...

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

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's RMAT designation is intended to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse, or cure serious or life-threatening diseases where ...

This case involves an appeal from Regeneron Pharmaceuticals, Inc.’s (Regeneron) efforts to prevent defendants from marketing biosimilar versions ...

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 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 ...

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 ...