Drug Approval | December 20, 2022
USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod
None of the observations are related to data integrity and management believes that they are addressable
None of the observations are related to data integrity and management believes that they are addressable
Global pharmaceutical company having a surgical business concept incepted in Dubai
EZHARMIA is the fifth innovative oncology medicine to be launched in Japan by Daiichi Sankyo in the past three years
This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting
The product is backed by required scientific proof and comparative bioequivalence studies
AUR101, with a good ADME/PK profile and high bioavailability, has demonstrated inhibition of IL-17A in whole blood from psoriasis patients
India now has 648 medical colleges in 2022 with a whopping 96% increase in the number of Government Medical Colleges (GMC) alone and a 42% increase in the private sector, since 2014
This is a phase two randomized, double-blind, parallel-group, placebo and active-controlled study
The company will submit an action plan on the observations and will engage with US FDA for next steps.
LG Chem will receive totaling up to $95.5 million for the China rights
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