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Results For "US-Food-and-Drug-Administration"

127 News Found

Biocon Biologics announces USFDA approval for Jobevne biosimilar Bevacizumab
Drug Approval | April 11, 2025

Biocon Biologics announces USFDA approval for Jobevne biosimilar Bevacizumab

Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis


SPARC announces submission of IND Application for SBO-154 to USFDA
News | April 04, 2025

SPARC announces submission of IND Application for SBO-154 to USFDA

The IND application supports the next phase of development of SBO-154


SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility
Drug Approval | March 22, 2025

SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility

The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483


Orchid Pharma's Alathur API facility successfully completes USFDA inspection
Drug Approval | February 20, 2025

Orchid Pharma's Alathur API facility successfully completes USFDA inspection

The Alathur facility specializes in the production of Cephalosporin antibiotics


GSK’s Penmenvy approved by FDA to help protect against MenABCWY
News | February 17, 2025

GSK’s Penmenvy approved by FDA to help protect against MenABCWY

Vaccine helps protect against five common disease-causing serogroups of Neisseria meningitidis (A, B, C, W and Y)


Briefs: Caplin Point Laboratories, Hikal and Cipla
Drug Approval | February 10, 2025

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru


FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness
Drug Approval | February 05, 2025

FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness

Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)


OneSource receives EIR with VAI classification from USFDA for BLD facility
Drug Approval | January 29, 2025

OneSource receives EIR with VAI classification from USFDA for BLD facility

OneSource operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies


Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer
Drug Approval | January 18, 2025

Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer

Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030