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Results For "FDA-approval"

438 News Found

USFDA clears Niramai's breast thermography device
News | March 14, 2022

USFDA clears Niramai's breast thermography device

The SMILE-100 System is a breast thermography device that helps healthcare personnel review, measure and analyze thermally significant indications in the breast region


Jardiance is first and only treatment approved in Europe for chronic heart failure
Drug Approval | March 07, 2022

Jardiance is first and only treatment approved in Europe for chronic heart failure

The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe


USFDA clears Kairos Pharma’s IND to treat prostrate cancer
Biotech | February 18, 2022

USFDA clears Kairos Pharma’s IND to treat prostrate cancer

Phase 2 clinical trial to begin in 2022 with participation by Cedars Sinai Medical Center, University of Utah, and City of Hope


LEO Pharma appoints Brian Hilberdink President of LEO Pharma, US
People | February 18, 2022

LEO Pharma appoints Brian Hilberdink President of LEO Pharma, US

Brian joins LEO Pharma from Novo Nordisk, U.S. where he served as Senior Vice President of Sales.


Launches and margin sustainability hold key for Glenmark: ICICI Direct
News | February 15, 2022

Launches and margin sustainability hold key for Glenmark: ICICI Direct

Key takeaways of Q3FY22 quarter & conference call highlights


USFDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences
Drug Approval | February 10, 2022

USFDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences

Adds five years of market exclusivity on approval


USFDA approves Genentech’s Vabysmo to treat causes of vision loss
Drug Approval | January 31, 2022

USFDA approves Genentech’s Vabysmo to treat causes of vision loss

Vabysmo is the only injectable eye medicine approved simultaneously in the US for wet AMD and DME, with flexible dosing regimens based on patient need


Control Print’s 3-ply surgical masks receive USFDA 510(K) authorisation
News | January 25, 2022

Control Print’s 3-ply surgical masks receive USFDA 510(K) authorisation

The company has been manufacturing masks since the Covid-19 outbreak in 2020


US FDA approves Idorsia’s insomnia drug
Drug Approval | January 21, 2022

US FDA approves Idorsia’s insomnia drug

Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain


Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021
News | January 12, 2022

Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021

This surpasses the number of approvals supported in 2020