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

Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on ...

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

BOSTON & MONTREAL, May 28, 2025--enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, ...

Molbreevi – a new inhaled formulation of the well-established and off-patent white blood cell stimulator molgramostim – is ...

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

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.

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 ...