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 ...

The US Food and Drug Administration (FDA) rejected three prior regulatory applications before granting approval.

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

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

The FDA's green light for GOMEKLI is a significant achievement for SpringWorks, especially as it comes with a rare pediatric disease priority review voucher, which could be valued at around $100 ...

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

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

Fresh from FDA approval for its paediatric stem-cell product, Mesoblast is pursuing consent for indications of heart disease ...

Novo Nordisk said on Wednesday it plan to file its experimental next-generation obesity drug CagriSema for regulatory approval during the first quarter of next year, slightly later than its previous ...

NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. NKGen is headquartered in Santa Ana, ...

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