Drug Approval | October 30, 2022
USFDA issues Form 483 for Parawada unit of Laurus Labs
The observation is procedural in nature and the company will address the observation within stipulated timelines.
The observation is procedural in nature and the company will address the observation within stipulated timelines.
The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses
RYALTRIS is a fixed-dose combination therapy that provides relief for the symptoms of SAR, both nasal and ocular, in one easy-to-use nasal spray
Rymti is indicated in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis, and paediatric plaque psoriasis
CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine
With the receipt of the EIR, the inspection stands successfully closed.
The drug is expected to cater to the fast growing Rheumatoid Arthritis, Plaque Psoriasis, JIA, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohns disease, HS and Uveitis markets
Collaboration focuses on developing and implementing real-world research to drive patient access to cancer medicines
Plant is part of the company's CAD $30 million capital investment in the site
Companies finalize termination with an agreed-upon settlement fee of $55M to be paid to Akebia
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