FDA Archives - Page 203 of 220

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FDA
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Travere Therapeutics Provides Regulatory Updates On Its Development Programs

August 3, 4:59 PM

PDUFA target action date for NDA for sparsentan in IgAN on-track for November 17, 2022 Company to utilize traditional approval process for sparsentan in FSGS following completion of the pivotal Phase 3 DUPLEX

TVTX

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FDA
News

‘The CDC is expected to update its guidance in the coming days for Covid-19 community control, including in schools’ -CNN Report

By Benzinga Newsdesk

August 3, 3:38 PM

https://www.cnn.com/2022/08/03/health/cdc-covid-guidance/index.html?utm_medium=social&utm_source=twcnnbrk&utm_content=2022-08-03T19%3A37%3A10&utm_term=link

SPY

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FDA Accepts MediWound’s Refiling For Severe Thermal Burns Therapy For Review

By Ragothaman Srinivasan

August 3, 10:22 AM

The U.S. Food and Drug Administration (FDA) has accepted for review MediWound’s (NASDAQ: MDWD) recently re-submitted Biologics License Application (BLA) for its lead asset NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.

MDWD

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FDA
News

AbbVie FDA Approves JUVÉDERM VOLUX XC For Improvement Of Jawline Definition

By Benzinga Newsdesk

August 3, 8:52 AM

Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of JUVÉDERM® VOLUX™ XC for the improvement of jawline definition in adults over the age of 21 with

ABBV

2 minute read

Cornerstone Pharmaceuticals Announces Successful Completion Of Phase 1b Clinical Trial For CPI-613 In Combination With Gemcitabine And Cisplatin In Patients With Biliary Tract Cancer

By Benzinga Newsdesk

August 3, 8:12 AM

Cornerstone Pharmaceuticals, Inc. (“Cornerstone” or the “Company”), a company focused on rare cancer therapeutics and formerly known as Rafael Pharmaceuticals, today announced the successful

RFL

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FDA
News

FDA Approved Coherus’ CIMERLI as the First and Only Interchangeable Biosimilar to Lucentis for All Five Indications, with 12 Months of Interchangeability Exclusivity

By Charles Gross

August 2, 8:06 PM

Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) announced today that the U.S.

CHRS

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FDA
News

Bicycle Therapeutics Announces Publication Of Article In Bioconjugate Chemistry, Describing An Extension Of Its Proprietary Technology Platform Based On Bicyclic Peptides

By Benzinga Newsdesk

August 2, 6:14 PM

Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that an

BCYC

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Detailed Data From Phase II Crenezumab Alzheimer’s Prevention Initiative Study In Autosomal Dominant Alzheimer’s Disease Presented At AAIC; Says Crenezumab Was Safe And Well Tolerated With No Cases Of ARIA-E Observed During The Up To Eight-Year Study

By Benzinga Newsdesk

August 2, 11:02 AM

Crenezumab was safe and well tolerated with no cases of ARIA-E observed during the up to eight-year study As previously reported, numerical differences favoring crenezumab over placebo were confirmed across the

ACIU

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FDA
News

Acurx Announces New Data Presentations From Ongoing Ph2 Clinical Trial Program Of Ibezapolstat For CDI At 16th Biennial Congress Of Anaerobe Society of America

By Benzinga Newsdesk

August 2, 9:02 AM

New data link beneficial microbiome changes in Ph2a CDI patients to earlier results from Ph1 healthy volunteers to predict potential anti-recurrence properties of ibezapolstat New in vitro data show ibezapolstat is

ACXP

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Applied DNA Initiates Analytical Validation Of PCR-based Diagnostic Test Specific To Monkeypox Virus

By Benzinga Newsdesk

August 2, 8:03 AM

Applied DNA Sciences, Inc. (NASDAQ:APDN) (the "Company"), a leader in polymerase chain reaction ("PCR")-based technologies, announced that its wholly-owned clinical laboratory subsidiary, Applied

APDN