FDA has announced the approval of LIB Therapeutics’ Lerochol (lerodalcibep-liga) for subcutaneous (SC) use as an adjunct to ...
In today’s Pharmaceutical Executive Daily, Eli Lilly reports positive topline Phase III results for retatrutide, the FDA expands Amgen’s Uplizna label into generalized myasthenia gravis subtypes, and ...
The FDA has awarded its latest national priority voucher to Johnson & Johnson’s Tecvayli (teclistamab-cqyv) in combination with daratumumab for the treatment of relapsed or refractory multiple myeloma ...
Per the terms of the agreement, Sobi is expected to pay upwards of $950 million upfront in cash to acquire Arthrosi.The deal ...
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 ...
TrumpRx lowers drug prices but doesn't address diagnosis and care access barriers, limiting its impact on patient outcomes. Pharma must develop DTP programs integrating education, testing, and ...
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 ...