The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses
The state-of-the-art commercial production plant will be built on a 95-acre site in Saarlouis, acquired at the end of 2024
The EU approval of DAWNZERA is an important milestone that reflects our ongoing commitment to bring this innovative medicine to people in need across the globe
The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients
Waskyra is an ex vivo gene therapy that uses patients’ own CD34+ hematopoietic stem and progenitor cells, genetically engineered with a lentiviral vector
Treatment typically requires frequent injections directly into the eye—an ongoing burden for patients and health systems alike
Experts caution that realizing AI’s potential requires careful management and risk mitigation
The current two-vial format requires healthcare professionals to mix a lyophilised antigen with a liquid adjuvant before administration
Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation
Full approval will depend on verification of clinical benefit in a confirmatory trial
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