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 has accepted for Priority Review the BLA for sibeprenlimab for the treatment of immunoglobulin A nephropathy in adults.

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

Moderna, Inc. (NASDAQ:MRNA) today announced that it had voluntarily withdrawn the pending Biologics License Application (BLA) ...

The author has a $2.75 Price Target on CytoDyn (CYDY) in the Next 6 to 12 months, representing significant upside from its ...

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

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 ...

Moderna has withdrawn the BLA for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after consulting with FDA.

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

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 ...

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 ...