Teva hits major biosimilar milestones with FDA nod and regulatory filings
The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia
The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia
The inspection is now closed, and no regulatory action has been recommended
The approval covers pediatric patients without a matched sibling donor for stem cell transplant
IntraSight Plus enables confident decision-making and better patient care,” Philips said, emphasizing efficiency, simplicity, and precision
Kedar Upadhye has also been appointed as Chief Financial Officer of Biocon Limited
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
Alkem’s semaglutide comes in a pre-filled disposable injection pen containing four doses for a month, priced at Rs. 1,800
SNV4818, the oral drug, is pan-mutant–selective PI3K? inhibitor aimed at treating HR+/HER2- breast cancer and potentially other solid tumors
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