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

Tag: FDA

Bayer Secures EU Approval for Lynkuet Menopause Treatment

Drug Development
Bayer has secured regulatory clearance in both the United States and the European Union for Lynkuet, a non-hormonal therapy for vasomotor symptoms (VMS), marking...

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 Announces Removal of Black Box Warnings on HRT Products

Americas
The U.S. Department of Health and Human Services (HHS) announced a major policy shift today aimed at re-establishing what it described as gold-standard scientific...

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...
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