FDA Archives - Page 128 of 220

2 minute read

Health Canada Grants License For Quidel Triagetrue High-Sensitivity Troponin I Test To Aid In The Diagnosis Of Myocardial Infarction

December 19, 4:18 PM

QuidelOrtho Corporation (NASDAQ:QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine,

QDEL

4 minute read

‘Takeda’s Phase 3 AURORA Study Provides Evidence Of Maribavir’s Clinically Meaningful And Durable Effect In Cytomegalovirus Infection In Hematopoietic Stem Cell Transplant Patients, Despite Missing Primary Endpoint’

By Benzinga Newsdesk

December 19, 3:32 PM

https://www.takeda.com/newsroom/newsreleases/2022/takedas-phase-3-aurora-study-provides-evidence-of-maribavirs-clinically-meaningful-and-durable-effect-in-cytomegalovirus-cmv-infection-in-hematopoietic-stem-cell-transpla

TAK

1 minute read

FDA Allows Bluebird Bio To Resume Sickle Cell Disease Studies In Patients Below 18, With Changed Protocol

By Vandana Singh

December 19, 2:48 PM

The FDA removed its partial clinical hold on Bluebird bio Inc’s (NASDAQ:BLUE) study for patients under the age of 18 in studies…

BLUE

1 minute read

Accelerate Diagnostics Submits 510(K) Application To FDA For Gram-Negative Menu Expansion And Breakpoint Updates For The Accelerate PhenoTest BC Kit

By Benzinga Newsdesk

December 19, 2:33 PM

Accelerate Diagnostics, Inc. (NASDAQ:AXDX) today announced that the Company has submitted a 510(k) application to the FDA for Gram-negative menu expansion and breakpoint updates for the Accelerate PhenoTest® BC

AXDX

2 minute read

Israeli Psychedelics Biotech Shares Latest Advancements, Moves Forward With Addictions Treatment

By Lara Goldstein

December 19, 11:28 AM

Psychedelics company Clearmind Medicine Inc. (NASDAQ: CMND) aims to bring its proprietary compound, CMND-100, to clinical trials while developing additional proprietary psychedelic compounds for next-generation novel drug candidates, according to CEO Adi Zuloff-Shani.

CMND

5 minute read

Altamira Therapeutics Provides Year-End 2022 Business Update; Promoted Covadonga Pañeda, From Chief Development Officer To Chief Operating Officer

By Benzinga Newsdesk

December 19, 9:51 AM

Altamira Therapeutics Provides Year-End 2022 Business Update Strategic BentrioTM partnering or divestiture process enters decisive phase Partnering or divestiture process for inner ear

CYTO

1 minute read

FDA
News

Albireo Submits Bylvay Alagille Syndrome Regulatory Filings To FDA, EMA

By Benzinga Newsdesk

December 19, 9:33 AM

- Gold standard Phase 3 ASSERT study supports supplementary filings in the U.S. and EU - ASSERT study demonstrated efficacy of Bylvay (odevixibat) in pruritus, bile acids and sleep with a low drug-related

ALBO

1 minute read

Arcutis Submits Supplemental New Drug Application For ZORYVE Cream 0.3% For Expanded Indication For The Treatment Of Plaque Psoriasis In Children Down To 2 Years Of Age

By Benzinga Newsdesk

December 19, 9:05 AM

Regulatory submission for the expanded indication is supported by data from two recently completed 4-week Maximal Usage Systemic Exposure (MUSE) studies in children ages 2 to 11 years with plaque psoriasis If

ARQT

2 minute read

Paratek Pharmaceuticals Announces Top Line Data From Pilot Efficacy Study For The Treatment Of Pulmonary Anthrax And Acceptance Of The Second Procurement Of NUZYRA Under BARDA Project BioShield

By Benzinga Newsdesk

December 19, 8:37 AM

Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) today announced positive top line data from a pilot rabbit efficacy study evaluating NUZYRA’s effectiveness in the treatment of pulmonary anthrax. In the study, a 100%

PRTK

2 minute read

FDA Lifts Partial Clinical Hold For bluebird bio’s Sickle Cell Disease Studies For Patients Under The Age of 18

By Benzinga Newsdesk

December 19, 8:31 AM

bluebird bio, Inc. (NASDAQ:BLUE) today announced that the U.S. Food and Drug Administration (FDA) lifted its partial clinical hold for patients under the age of 18 in studies evaluating lovotibeglogene autotemcel

BLUE