The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
The primary objective of the study is to assess the safety and tolerability of SUVN-I6107 by monitoring adverse events (AEs), clinical laboratory, vital signs and electrocardiographs
Acquisition expands high-value medical platform
This product is an oral SYK inhibitor and suppresses platelet destruction by macrophages and platelet depletion
This strategic move aims to address the increasing global demand for biologics, enhancing ProBioGen's ability to support partners from cell line development t
Successfully transformed the organization from a two-country operation focused on development and manufacturing to a fully integrated company with a strong commercial engine bringing us closer to patients in over 120 countries
These initiatives will strengthen the company’s capital base, providing financial flexibility for future
These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route
The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A
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