Organon (NYSE: OGN) received FDA acceptance to review a supplemental New Drug Application for its hormone free contraceptive ...
The pharmaceutical industry is entering a new era of increasingly specialized therapies that require more intensive patient ...
In June of 2026, Organon completed its agreement to exclusively license global rights to Sebela’s MIUDELLA. MIUDELLA is a hormone-free, copper intrauterine device (IUD) indicated for the prevention of ...
Top US Food and Drug Administration (FDA) officials said the agency is open to novel, “innovative approaches” to the clinical ...
The FDA is focusing more attention than usual on psychedelics this month as the prospect of the first agency approval for the ...
EMPAVELI-treated adolescents achieved a 75% relative reduction in proteinuria within 6 months versus placebo EMPAVELI is the only approved ...
EMPAVELI-treated adolescents achieved a 75% relative reduction in proteinuria within 6 months versus placebo ; EMPAVELI is the only approved treatment for adolescents with C3G and ...
This week, a Senate committee scheduled a hearing for President Trump’s nominee to lead FDA, new reporting sheds light on the ...
ACACIA-HCM is the First Phase 3 Clinical Trial to Successfully Demonstrate Statistically Significant Improvements Across Both Patient-Reported ...
Biogen published results from a prespecified adolescent subgroup analysis of the Phase 3 VALIANT study evaluating EMPAVELI (pegcetacoplan) in the Clinical Journal of the American Society of Nephrology ...
The FDA is reviewing an sNDA to extend the duration of use for the hormone-free Miudella intrauterine system from 3 years to up to 6 years.
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