Drug Approval | October 16, 2024
Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
SIBUR is developing a special grade of polycarbonate compatible with radiation sterilization
MNI is dedicated to developing and offering phytochemical (plant-based) products and healthcare solutions, aimed at treating metabolic syndrome
NMC to continue its efforts to improve and enhance the quality of medical education in the country
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
The collaborations will help curate industry focused courses such as Advanced Certification courses for healthcare professionals in Healthcare Marketing, Healthcare Technology and Specialized Clinical Fellowship Level programs with university accreditation
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
Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)
Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India
Stringent regulatory environments can make OEMs reluctant to change processes and materials for approved medical devices
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