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

GOMEKLI™ is an oral, small molecule MEK inhibitor approved in the United States for the treatment of adult and pediatric ...

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

Fresh from FDA approval for its stem-cell product for paediatric graft-versus-host disease, Mesoblast is pursuing consent for ...

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

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

In an important regulatory win for Denmark’s Novo Nordisk, the US Food and Drug Administration (FDA) yesterday approved ...

The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...

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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 ...

African National regulatory agencies (NRAs) under the World Health Organisation’s (WHO) maturity level 3, have signed a ...