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FDA Approvals

AI-Assisted Fetal Screening Sets New Standard at Mount Sinai

Americas
Mount Sinai obstetricians have become the first in New York City to use FDA-cleared artificial intelligence technology designed to enhance prenatal ultrasound evaluations for...

FDA Clears Novartis Itvisma Gene Replacement Therapy for SMA

Americas
Novartis has secured US Food and Drug Administration (FDA) approval for Itvisma (onasemnogene abeparvovec-brve), a gene replacement therapy for spinal muscular atrophy (SMA). The clearance...

FDA Clears Merck’s Keytruda with Padcev for Bladder Cancer

Americas
Key takeaways: Merck’s FDA clearance introduces the first PD-1 inhibitor and ADC combination for cisplatin-ineligible MIBC patients, widening its position in the bladder cancer...

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 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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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

Whitepapers 0
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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