Drug Approval | July 26, 2024
USFDA inspects Gland Pharma’s Dundigal facility
The inspection was concluded with two 483 observations
The inspection was concluded with two 483 observations
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant
The company will address these observations within the stipulated timeline
Utidelone can penetrate BBB due to its unique physicochemical characteristics and insusceptibility to P-glycoprotein-mediated efflux
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness
Through its rare kidney disease portfolio, Novartis is committed to exploring a range of treatment options with different modes of action to slow IgAN progression
The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States
Lupin updates on shipment of Mirabegron ER Tablets
With this, for all our USFDA facilities, EIRs are in place
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