News

MassDevice2d
Terumo launches Roadsaver carotid stent following FDA approval
Terumo Interventional Systems has announced the early commercial availability of its FDA-approved Roadsaver Carotid Stent ...
FDA approves topical foam for plaque psoriasis of the scalp and body
The U.S. Food and Drug Administration has approved Arcutis Biotherapeutics' Zoryve (roflumilast) topical foam 0.3% for the ...
Healio3d
FDA approves transcatheter mitral valve replacement system for high surgical risk patients
Abbott announced the FDA approved its transcatheter mitral valve replacement system for patients with severe mitral annular ...
Fierce Pharma4d
FDA calls for additional manufacturing data in refusal letter for Savara's respiratory asset
Despite hiring a commercial chief and sponsoring disease awareness efforts last year, Savara will have to wait a while longer ...
Healio4d
FDA grants rare pediatric disease designation for Stargardt disease gene therapy
The FDA granted rare pediatric disease designation for OCU410ST, a gene therapy designed to treat ABCA4-associated ...
Ocugen wins FDA rare pediatric disease status for genetic eye disorder treatment
Ocugen ( NASDAQ: OCGN) disclosed on Tuesday that its gene therapy candidate, OCU410ST, has been granted rare pediatric ...
MassDevice3d
FDA clears next-gen endoscopes from Olympus
Olympus announced that it received FDA 510(k) clearance for its EZ1500 series endoscopes featuring Extended Depth of Field ...
Zacks Investment Research on MSN2d
CADL Up as FDA Grants RMAT Status to CAN-2409 in Prostate Cancer
Candel Therapeutics CADL announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to ...
Tioga Publishing3d
Olympus secures FDA clearance for most advanced imaging endoscopes
Compared to the previous generation of Olympus scopes, the technology provides improved visibility and less blurring, the ...