US FDA issues 17 observations for Biocon Biologics sites
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
On the precision oncology front, expanded larotrectinib data will focus on efficacy and safety findings for pediatric and adult patients with NTRK gene fusion-positive solid tumors
The OCEANIC program will start with two Phase III studies investigating the efficacy and safety of asundexian in prevention of stroke
Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)
3D CMOS chip for connecting electroactive tissues and organoids to software
Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis
Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA
The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
Collaboration supports multiple discovery efforts, including vaccines
APIC is a contract development and manufacturing organization (CDMO) that offers a wide range of services such as synthetic route design, pilot manufacturing, investigational medical manufacturing, and commercial production, by making full use of integrated processes that combine organic synthesis technologies and biotechnologies it has cultivated over many years
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