It targets to initiate first-in-human clinical trials in patients with Essential Thrombocythemia and Polycythemia Vera.
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USFDA conducted the Good Manufacturing Practices (GMP) inspection from October 24 to October 30 in 2024.
The certification came after a successful inspection by the Finnish Medicines Agency on behalf of EMA from March 10 to March 14, 2025
The partnership will work on a new biological entity (NBE) in the immuno-oncology field to better treat cancer.
Here are some of the stocks that may see significant price movement today: Aditya Birla Real Estate, Shilpa Medicare, Swiggy, etc.
No regulatory issues were raised by the USFDA at Unit-2 during the inspection, the company said in a regulatory filing.
Shilpa Medicare said it has completed Phase 3 trials for SMLNUD07 – Nor Ursodeoxycholic Acid (Nor UDCA) tablets in 165 NAFLD patients in India.
The certification followed a successful inspection by the European Medicines Agency, Austria, held from September 24 to September 26 at the Nacharam, Hyderabad facility.
This FDA approval is a milestone in cancer therapy as it presents a more convenient and precise alternative to the traditional tablet forms.
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