Certification by TÜV SÜD Product Service GmbH reinforces the company's commitment to globally benchmarked standards in safety, quality, and performance
The company’s broader OX2R portfolio includes clinical and preclinical assets with potential applications across neurological, neurodegenerative, and neuropsychiatric conditions
The partnership has already launched with five active development programs, with both organizations jointly managing regulatory strategy and documentation under a structured, milestone-gated framework
The inspection is now closed, and no regulatory action has been recommended
The trial demonstrated that immune responses in children were non-inferior to adults, with a similar safety profile after two standard doses of MVA-BN
Price of the starting dose of Ozempic and Wegovy reduced by 36% and 48% respectively
The approval covers pediatric patients without a matched sibling donor for stem cell transplant
Beyond clinical trials, real-world evidence is adding weight to AbbVie’s claims
Otsuka will pay $700 million to Transcend shareholders at closing, with an additional $525 million in contingent payments tied to future sales milestones
TERN-701, a next-generation therapy targeting chronic myeloid leukemia (CML), a form of blood cancer that still presents treatment challenges despite decades of advances
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