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ACHEMA MIDDLE EAST 2026
17TH Global Drug Delivery & Formulation Summit 2026

FDA Approvals

FDA Unveils Plausible Mechanism Pathway for Custom Therapies

Americas
The US Food and Drug Administration (FDA) has unveiled a new regulatory framework designed to accelerate the approval of personalised therapies by easing traditional...

Henlius, Organon Secure FDA Approval for PERJETA Biosimilar

Americas
Shanghai Henlius Biotech and Organon Announced that the US Food and Drug Administration (FDA) has granted approval to the Biologics License Application for POHERDY®...

FDA Grants Approval for CAPLYTA for MDD Treatment in Adults

Americas
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted approval for CAPLYTA (lumateperone) to be used as an adjunctive...

FDA Approves J&J’s DARZALEX FASPRO for HR-SMM in Adults

Americas
Johnson & Johnson said the U.S. Food and Drug Administration (FDA) has cleared DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for use as a single-agent treatment...

FDA Approves UCB’s KYGEVVI for Thymidine Kinase 2 Deficiency

Americas
UCB, a leading global biopharmaceutical company, has announced that KYGEVVI has received FDA approval for the treatment of adults and pediatric patients diagnosed with...

FDA Unveils Initiative for Faster Biosimilar Development

Americas
The U.S. Food and Drug Administration (FDA) has unveiled a major initiative aimed at cutting both the time and cost required to develop biosimilar...

FDA Approves Omvoh by Eli Lilly for Ulcerative Colitis

Americas
Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved a new single-injection, once-monthly maintenance option (200 mg/2...

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White Papers

The Future of Digital Health

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The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution....

Five Best Practices to Deliver Exceptional Multichannel Experiences

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A one-size-fits-all customer journey no longer works. In the age of the consumer, the quality of the interaction is paramount. In this paper, we...

The Impact and Use of Social Media in Pharmacovigilance

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Social media presents new channels and methods for biopharmaceutical companies to move away from traditional pharmacovigilance (PV) systems and safety reporting methods towards more...

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