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Results For "FDA-approval"

460 News Found

USFDA approves Rinvoq for ulcerative colitis
Drug Approval | March 17, 2022

USFDA approves Rinvoq for ulcerative colitis

First approved in 2019, Rinvoq is a JAK inhibitor approved for four indications across gastroenterology, dermatology and rheumatology


I Peace triples GMP cell manufacturing by expanding CDMO facility
Biotech | March 15, 2022

I Peace triples GMP cell manufacturing by expanding CDMO facility

The facility registration, along with DMF registration and GMP certification provides peace of mind to clients looking to use our iPSCs for clinical and commercial use in the United States, Japan, and other global markets


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