FDA Clears Merck’s Keytruda with Padcev for Bladder Cancer
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...
Alvotech and Advanz Pharma Secure EC Approval for Gobivaz
Key takeaways:
EC approval of Gobivaz gives Alvotech and Advanz Pharma a stronger foothold in Europe’s competitive biosimilar segment.
The authorisation widens the companies’...
Bayer Secures EU Approval for Lynkuet Menopause Treatment
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
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
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
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
Merck announced that it will acquire Cidara Therapeutics, Inc., after both companies confirmed they have signed a definitive agreement. The deal, executed through a...
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The Future of Digital Health
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
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
Social media presents new channels and methods for biopharmaceutical companies to move away from traditional pharmacovigilance (PV) systems and safety reporting methods towards more...