FDA Archives - Page 148 of 220

4 minute read

Bicycle Therapeutics Announces First Patient Dosed In BT8009 Phase II Expansion Cohorts And Provides Program Update

November 8, 8:05 AM

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 updates from

BCYC

3 minute read

Reported Late Monday, Intercept Announces Development Program For Next-Generation FXR Agonist INT-787 In Severe Alcohol-Associated Hepatitis

By Benzinga Newsdesk

November 8, 1:18 AM

First-in-human data shared at The Liver Meeting® 2022 supported a favorable safety and tolerability profile for INT-787 in healthy adults Company announces severe alcohol-associated hepatitis (sAH), a

ICPT

2 minute read

Werewolf Therapeutics To Present Preclinical Data At Society For Immunotherapy Of Cancer Annual Meeting And Participate In Upcoming Investor Conferences

By Benzinga Newsdesk

November 7, 5:59 PM

Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (NASDAQ:HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to

HOWL

1 minute read

BioMarin Announces Incremental Progress On Biologics License Application Review For Valoctocogene Roxaparvovec AAV Gene Therapy For Adults With Severe Hemophilia A Program

By Benzinga Newsdesk

November 7, 5:58 PM

FDA Pre-Licensure Inspection of Gene Therapy Manufacturing Facility Scheduled FDA Requests Submission of Upcoming 3-Year Data Analysis from Phase 3 GENEr8-1 Study Current PDUFA Target Action Date of March 31, 2023,

BMRN

1 minute read

Bio-Rad And Nuprobe Enter Into An Exclusive Licensing Agreement For Digital PCR Applications; Nuprobe USA To Exclusively License Its Allele Enrichment Technologies To Co For Development Of Multiplexed Digital PCR Assays

By Benzinga Newsdesk

November 7, 3:34 PM

Bio-Rad Laboratories, Inc. (NYSE:BIO), a global leader in life science research and clinical diagnostic products, and NuProbe USA, a genomics and molecular diagnostics company, today announced the signing of a licensing

BIO

6 minute read

Mirum Presents New Data From LIVMARLI Phase 3 PFIC Study And ALGS Infant Study In Late-Breaker Presentations At The Liver Meeting Of AASLD; Phase 3 MARCH Study Meets Primary Endpoint

By Benzinga Newsdesk

November 7, 2:04 PM

- Phase 3 MARCH study meets primary endpoint and demonstrates statistical significance across key endpoints in all PFIC types. Receives Best of Liver Meeting

MIRM

3 minute read

SeaStar Medical’s Lead Product Candidate, The Selective Cytopheretic Device, Included In Consensus Statement For Pediatric Acute Kidney Injury In First Pediatric Acute Disease Quality Initiative Meeting

By Benzinga Newsdesk

November 7, 1:36 PM

– The SCD is currently being evaluated by the FDA for a Humanitarian Device Exemption (HDE) marketing approval for use in children (> 20 kgs) with AKI – The Company expects the FDA to

ICU

4 minute read

AbbVie Announces Late-Breaking Results From Phase 2 Exploratory NOVA Trial Of Novel Investigational Neurotoxin AGN-151607 For The Prevention Of Postoperative Atrial Fibrillation In Cardiac Surgery Patients, Primary Endpoint Was Not Met

By Benzinga Newsdesk

November 7, 1:35 PM

Primary endpoint was not met for the modified intent-to-treat (mITT) population; however, clinical benefit observed in coronary artery bypass graft (CABG) patients

ABBV

5 minute read

Milestone Pharmaceuticals Announces New Data from Phase 3 RAPID Trial Of Etripamil Nasal Spray in Patients with PSVT During Late-Breaking Session At AHA Scientific Sessions 2022; Says Trial Met Primary Endpoint

By Benzinga Newsdesk

November 7, 1:15 PM

Trial met its primary endpoint, with 64.3% of patients receiving etripamil converting to sinus rhythm within 30 minutes compared to 31.2% on placebo (HR = 2.62, p<0.001) Median time to

MIST