The FDA’s approval of Uplizna for antibody-positive generalized myasthenia gravis introduces a twice-yearly CD19-targeted therapy option for the rare autoimmune condition. The FDA has approved Amgen’s ...
Brent Saunders returned to Bausch + Lomb in 2023 to help address unmet needs in eye care, focusing on innovation and ...
PE: How are global regulatory agencies adjusting their policies for biosimilars? Woollett: The clear leaders in the space of ...
With the first 15 CNPVs now awarded, we can begin to see a clear pattern: the winners weren’t just those with breakthrough science, but those with operational models ready for an accelerated, ...
In today’s Pharmaceutical Executive Daily, new analysis outlines what it may truly cost to fix the biopharma ecosystem, the ...
M&A in biopharma is shaped by policy uncertainties, tariffs, and potential marketing rule changes, influencing strategic ...
The Trump administration has taken steps to strengthen domestic manufacturing across all industries since coming into office ...
DTC prescription drug models are reshaping the pharma industry by altering pricing dynamics and enhancing patient access, ...
Lilly’s first Phase III results for retatrutide show unprecedented weight loss and marked reductions in osteoarthritis pain, ...
While pharmaceutical pricing has been a controversial topic for many years, a new spotlight was shone on it over the past 12 months.
OTR Therapeutics and Zealand Pharma collaborate to develop novel metabolic disease treatments, with a potential deal value of ...
PE: How will recent regulatory developments at FDA impact feasibility assessments in clinical planning? Woollett: It’s ...