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

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 ...

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

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

Moderna, Inc. (NASDAQ:MRNA) made a name for itself by quickly developing an effective coronavirus vaccine when the world ...

CAMBRIDGE, MA / ACCESS Newswire / May 21, 2025 / Moderna, Inc. (Nasdaq:MRNA), today announced that in consultation with the U ...

announced today that the U.S. Food and Drug Administration has accepted for review the Biologics License Application (BLA) submission by REGENXBIO Inc. (REGENXBIO; Headquarters: Rockville ...

PARAMUS, N.J., May 14, 2025 /PRNewswire/ -- 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 ...

BOTOX® Cosmetic is not equivalent to other preparations of botulinum toxin products, and therefore, Units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into Units ...