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ACHEMA MIDDLE EAST 2026
5th LNP Formulation & Process Development Summit

Tag: FDA

FDA Grant Approval for Opzelura Cream for Pediatric Eczema

Drug Development
The U.S. Food and Drug Administration has granted approval to Incyte’s eczema cream, Opzelura, for use in children aged 2 to 11 years, the...

Amneal Secures FDA Approval for Sodium Oxybate Oral Solution

Drug Development
Amneal Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company’s sodium oxybate oral solution 500...

US FDA Tightens Oversight on Misleading Drug Advertising

Facilities & Operation
The U.S. Food and Drug Administration (FDA) announced that it will issue approximately 100 cease-and-desist enforcement notices alongside thousands of warning letters directed at...

US FDA Approves Bladder Cancer Treatment Inlexzo from J&J

Drug Development
The U.S. Food and Drug Administration has granted approval to Johnson & Johnson’s drug delivery system for a specific type of bladder cancer. The...

FDA Approves Recombinant VWF Treatment in Pediatric Patients

Drug Development
The US Food and Drug Administration (FDA) has expanded the indication for recombinant von Willebrand factor (VWF), marketed as Vonvendi, to include children with...
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