FDA Archives - Page 139 of 220

Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM), today announced the decision to discontinue the OHANA study of volixibat in intrahepatic cholestasis of pregnancy (ICP) due to enrollment feasibility. ICP is a setting of

MIRM

1 minute read

‘Immutep Enters Into Second Clinical Trial Collaboration Agreement With Merck KGaA, Darmstadt, Germany, And Pfizer For New Combination Study Of Its LAG-3 Candidate. Eftilagimod Alpha, And Avelumab To Treat Urothelial Cancer’

By Benzinga Newsdesk

November 28, 5:23 PM

Immutep Limited (asx.com.au)

IMMP

2 minute read

NanoVibronix Receives FDA 510K Premarket Clearance for PainShield Plus, Its Dual-Actuator Ultrasound Pain Therapy Device

By Benzinga Newsdesk

November 28, 4:21 PM

Achieves Key Milestone to Advance Commercialization NanoVibronix, Inc., (NASDAQ:NAOV), a medical device company utilizing the Company's proprietary and patented low intensity surface acoustic wave (SAW) technology,

NAOV

1 minute read

Traders Circulate Barclays Note Saying Catalent Had Their 483s Cleared Over The Weekend. The FDA Cleared Both The Belgium And Bloomington Facilities 483s With Voluntary Action Indicated Designations; A Minimally Acceptable State Of Compliance Was Met

By Benzinga Newsdesk

November 28, 1:56 PM

Barclays saying that CTLT had their 483s were cleared over the weekend the FDA cleared both the Belgium and Bloomington facilities’ 483s over the weekend with Voluntary Action Indicated (VAI) designations.

CTLT

1 minute read

European Medicines Agency Says EMA Published The Assessment Report For Spikevax Supporting Its Extension Of Indication For Use In Children Aged 6 Months To 5 Years

By Benzinga Newsdesk

November 28, 11:41 AM

- Reuters

MRNA

4 minute read

Gilead And Arcus Biosciences Announce Positive Update On Joint TIGIT Program From Interim Analysis of ARC-7 Study In Non-Small Cell Lung Cancer; Shares Spike Higher

By Benzinga Newsdesk

November 28, 9:32 AM

– Fourth Interim Analysis Shows Continued Clinically Meaningful Differentiation Across All Efficacy Measures, Including PFS, in Both Domvanalimab-Containing Arms Compared to the Anti-PD-1 Zimberelimab Monotherapy

GILD

1 minute read

CinCor Pharma Announces Topline Data For Phase 2 HALO Trial Evaluating Selective Aldosterone Synthase Inhibitor Baxdrostat On Uncontrolled Hypertension Did Not Meet Its Primary Endpoint

By Benzinga Newsdesk

November 28, 8:33 AM

Primary endpoint in Intention to Treat (ITT) was not met despite large absolute reductions in Systolic Blood Pressure (SBP) 12.6 mmHg placebo-adjusted reduction in SBP with 2 mg baxdrostat in a pre-specified subgroup

CINC

1 minute read

Sarepta Therapeutics Announces That U.S. FDA Has Accepted For Filing And Granted Priority Review For The Biologics License Application For SRP-9001, Sarepta’s Gene Therapy For The Treatment Of Ambulant Individuals With Duchenne Muscular Dystrophy

By Benzinga Newsdesk

November 28, 8:05 AM

– Regulatory action date of May 29, 2023 – SRP-9001 would be the first gene therapy for Duchenne, a one-time treatment designed to treat the underlying cause of DMD by delivering a functional

SRPT