Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
Eugia Steriles receives EIR from USFDA for new injectable facility
Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous
The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices
The recent inspection covered both cGMP and PAI processes
This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II
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