U.S. FDA approves CAPVAXIVE (V116), specifically designed for pneumococcal disease in adults
Across four Phase 3 studies, CAPVAXIVE demonstrated robust immune responses in both vaccine-naïve and vaccine-experienced adult…
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Browsing Tag
United States Food and Drug Administration (USFDA)
Agomab receives FDA Orphan Drug Designation for AGMB-447 in idiopathic pulmonary fibrosis
AGMB-447 is an inhaled lung-restricted ALK5-inhibitor currently in a Phase 1 clinical trial Agomab Therapeutics announced that…
Lupin Receives Approval from U.S. FDA for Travoprost Ophthalmic Solution USP
It is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Strides arm receives EIR for its US facility
Strides Pharma Inc received EIR from the United States Food and Drug Administration (USFDA) for the inspection conducted at its…