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.
Ghana News Agency (GNA) on MSN1d
FDA leads 7 African regulators to foster trust and accelerate access to medicinesThe Ghana Food and Drugs Authority (FDA) has spearheaded a joint initiative with National Regulatory Authorities (NRAs) in ...
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 ...
The intravenous antibiotic Emblaveo, a combination of aztreonam and avibactam approved in Europe last year, was developed in ...
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, ...
Today, adoption of digital health faces some of the same barriers — scepticism, budget limitations, high expectations, and a ...
In the Phase 2 open-label Oral Anaphylm Symptom Intervention Study ("OASIS”) study, adults with Oral Allergy Syndrome (n=36) received Anaphylm under different conditions, including single and repeat ...
The next FDA Commissioner could solve two big problems with one powerful policy: encourage independent testing of both ...
African National regulatory agencies (NRAs) under the World Health Organisation’s (WHO) maturity level 3, have signed a ...
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