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
India’s first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma
Expansion includes a new 5-story, 136k sq. ft. multipurpose building in Sejong
Clariant is launching high-performing pharmaceutical ingredients to support the evolution of safe and effective medicines
The inspection conducted by EDQM at its Visakhapatnam facility
The inspection concluded with the issuance of a form 483 with five observations
The sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious
Fermenta Biotech’s API manufacturing facility receives EU GMP compliance certificate
USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
Subscribe To Our Newsletter & Stay Updated
