Organon has reported a cumulative six-year Pearl Index of 0.93 and an estimated pregnancy rate of 3.9% for the hormone-free MIUDELLA intrauterine system. The findings support an FDA application to extend its approved use from three to six years, with a decision expected in the second quarter of 2027.
FDA approves J&J's teclistamab plus daratumumab for relapsed myeloma from second line. Analyse the MajesTEC-3 data, safety profile, and what this changes for treatment.
Organon’s etonogestrel implant NEXPLANON has received FDA approval for extended use up to five years, marking a significant regulatory win for the women’s health–focused pharmaceutical company. The decision, which comes via a supplemental new drug application (sNDA), builds on existing data supporting the implant’s high efficacy and safety profile and broadens its potential utility among