Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...

GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...

The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...

SANTA ANA, Calif. - NKGen Biotech, Inc. (NASDAQ: NKGN), a clinical-stage biotechnology company with a current market capitalization of $17 million, has received Fast Track designation from the U.S.

GNA-The Ghana Food and Drugs Authority (FDA) has spearheaded a joint initiative with National Regulatory Authorities (NRAs) ...

The intravenous antibiotic Emblaveo, a combination of aztreonam and avibactam approved in Europe last year, was developed in ...

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

The FDA’s new approval makes the drug the first GLP-1 ... senior vice president of clinical development, medical & regulatory affairs for Novo Nordisk, maker of Ozempic — in a press release.

The approval comes after the FDA rejected AXS-07 for manufacturing issues in 2022. Before that, Axsome’s regulatory timeline ...