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news.US FDA rejects approval of Unicycive’s kidney disease therapy
This decision was issued in a Complete Response Letter (CRL) which cited deficiencies at a third-party manufacturing facility producing OLC. The FDA did not raise concerns related to
This decision was issued in a Complete Response Letter (CRL) which cited deficiencies at a third-party manufacturing facility producing OLC. The FDA did not raise concerns related to
Under this agreement, Innovent will handle the marketing, distribution and promotion of the product within the region, while Eli Lilly will continue to manage manufacturing, supply and development. Verzenios
The MOIP has issued Patent Number 10-2960889, providing protection for Anixa’s breast cancer vaccine approach in South Korea through 2040. This specific composition-of-matter patent is exclusively licensed from
Under the terms of the deal, Theravance Biopharma shareholders will receive $17 per share. Shareholders will also receive a contingent value right (CVR) entitling them to 80% of
The FDA has requested further information, primarily focusing on the manufacturing control strategy of the biological component of NASP and on deficiencies related to contract manufacturing facilities. It
This Jaypirca CHMP recommendation for CLL applies across all lines of therapy, regardless of previous Bruton tyrosine kinase (BTK) inhibitor treatment. Following this recommendation, the Jaypirca application moves
The initial phase of the partnership, valued at up to $15m and running until 2027, may be expanded if scientific milestones are met and both parties agree. The
Ionis will retain the responsibility for commercialising the RNA-targeted medicine within the US and will remain the global lead for development activities. Under the agreement, Recordati will handle regulatory
The authorisation applies to adults with resectable MIBC who cannot be treated with cisplatin-based chemotherapy. It makes the combination the first regimen that pairs a programmed death-1 (PD-1)
Frazier Life Sciences led the financing round along with new investors EQT Life Sciences, Forbion, Monograph and Wellington Management. LifeArc Ventures, Oxford Science Enterprises and the University of