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Americas

      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...

      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...

      Merck Announces Acquisition of Cidara Therapeutics at $9.2 B

      Americas
      Merck announced that it will acquire Cidara Therapeutics, Inc., after both companies confirmed they have signed a definitive agreement. The deal, executed through a...

      Novartis Opens Radioligand Therapy Manufacturing Plant in US

      Americas
      Novartis, a leader in innovative medicines, has launched a 10,000-square-foot radioligand therapy (RLT) manufacturing facility in Carlsbad, California. The site marks an important step...

      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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      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....

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      The Impact and Use of Social Media in Pharmacovigilance

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