Regulatory & Compliance

Can the CPHI Summit Close the Sustainability Gap in Pharma?
Management & Regulatory Can the CPHI Summit Close the Sustainability Gap in Pharma?

The shift in the pharmaceutical landscape has reached a point where environmental stewardship is no longer an optional component of corporate social responsibility. For decades, the global pharmaceutical sector operated under the assumption that life-saving patient outcomes justified a heavy

How Safe Is the WiSE Wireless Cardiac Pacing System?
Tech & Innovation How Safe Is the WiSE Wireless Cardiac Pacing System?

The rapid integration of wireless technologies into the human cardiovascular system has introduced a set of unprecedented clinical challenges that force medical professionals to reconsider the traditional boundaries of patient safety and device efficacy. EBR Systems, a prominent medical technology

LITMUS Study Validates Imaging Endpoints for MASLD Trials
Tech & Innovation LITMUS Study Validates Imaging Endpoints for MASLD Trials

The clinical research community has long grappled with the invasive necessity of liver biopsies, yet the publication of the LITMUS Imaging Study in Nature Medicine marks a definitive turning point in the pursuit of non-invasive diagnostics. For decades, the liver biopsy stood as the undisputed gold

FDA Briefing Casts Doubt on Capricor’s DMD Cell Therapy
Research & Development FDA Briefing Casts Doubt on Capricor’s DMD Cell Therapy

The pursuit of effective treatments for Duchenne muscular dystrophy has shifted focus toward managing cardiomyopathy, which currently stands as the most common cause of mortality for patients entering their second or third decade of life. Capricor Therapeutics recently faced significant headwinds

FDA Validates GTx-104 Clinical Data as Grace Eyes Approval
Management & Regulatory FDA Validates GTx-104 Clinical Data as Grace Eyes Approval

The critical window following an aneurysmal subarachnoid hemorrhage often determines the thin line between a successful recovery and permanent neurological deficit for thousands of patients every single year. These life-threatening brain bleeds require immediate and precise pharmacological

Can Pfizer’s GBS6 Navigate the Regulatory Gauntlet?
Research & Development Can Pfizer’s GBS6 Navigate the Regulatory Gauntlet?

Group B Streptococcus remains a formidable adversary in the realm of neonatal health, contributing to significant rates of sepsis, pneumonia, and meningitis in infants globally. Pfizer’s hexavalent Group B Streptococcus vaccine, known as GBS6, has recently reached a pivotal moment in its

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