Drug Approval | September 12, 2021
US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
TCS provides clinical research services such as clinical data management, regulatory affairs, pharmacovigilance, risk-based monitoring, biostatistics and programming, medical writing, medical affairs and medico marketing, and health economics and outcomes research
First launched in 2005, pharmaREADY is a fully integrated, regulatory compliant, web-based platform to create, view, and manage global regulatory submissions
The World Health Organisation (WHO), has felt the need to conduct this training to build local capacities in poor countries to bridge the gap and enhance local production
Takeda is establishing the capability to manufacture TAK-019 (known outside Japan as NVX-CoV2373) at its facilities in Japan and aims to begin distribution in the early calendar year 2022
It adds Rezurock (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD)
The global CRAMS segment is expected to clock 6.2% CAGR over CY21-26E to touch US $ 170 billion
The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India
RSV is a common and pervasive cause of severe acute respiratory illness in older adults with no vaccine currently available
At its meeting, the board also approved raising the company’s authorised share capital to Rs. 42.50 crores from Rs. 37.50 crores.
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