FDA - Spark Newswire

5 minute read

Alnylam Presents Additional Results From The APOLLO-B Phase 3 Study Of Patisiran In Patients With ATTR Amyloidosis With Cardiomyopathy At Heart Failure Society Of America Annual Meeting

Yesterday, 2:03 PM

– New Data Further Support Potential for Patisiran to be an Effective Treatment for Cardiomyopathy of ATTR Amyloidosis – – Data from Exploratory Endpoints, Including Cardiac Biomarkers and Imaging,

ALNY

1 minute read

FDA Says Livanova Recalls Lifesparc System For Risk Of Unintentional Extended Pump Stop During Controller Critical Failure

By Benzinga Newsdesk

Yesterday, 10:49 AM

- Reuters

LIVN

2 minute read

Edesa Biotech Reports Statistically Significant Mortality Reductions In Phase 2 ARDS Drug Study; Says ‘EB05 demonstrated an 84% reduction in the risk of dying when compared to placebo’

By Benzinga Newsdesk

Yesterday, 8:02 AM

Mortality reduction in critically ill subjects at 28 days revised favorably, statistically significant EB05 demonstrated an 84% reduction in the risk of dying when compared to placebo Clinical Study Report

EDSA

1 minute read

Zealand Pharma Announces Results From Phase 3 Trial Of Glepaglutide; Glepaglutide Treatment Met Primary Endpoint

By Benzinga Newsdesk

Yesterday, 6:17 AM

Zealand Pharma Announces Positive Results from Phase 3 Trial of Glepaglutide in Patients with Short Bowel Syndrome (EASE 1) Glepaglutide treatment met the primary endpoint with twice weekly dosing achieving a

ZEAL

6 minute read

Rocket Pharmaceuticals Announces Updates From Phase 1 Clinical Trial For RP-A501

By Benzinga Newsdesk

Yesterday, 6:03 AM

— Pediatric efficacy data for both patients show initial improvements across clinical, functional and biomarker endpoints with six to nine months of follow-up; positive results including protein

RCKT

1 minute read

FDA
News

Amylyx Pharmaceuticals Receives FDA Approval Of Relyvrio For Treatment Of Amyotrophic Lateral Sclerosis

By Michael Horton

September 29, 4:38 PM

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216660

AMLX

3 minute read

Iridex Showcases Its Non-Incisional Treatments For Glaucoma, Introduces Sweep Management Software, And Hosts 8 Physician Presentations At AAO 2022

By Benzinga Newsdesk

September 29, 4:08 PM

MicroPulse® Transscleral Laser Therapy (TLT), continuous-wave transscleral cyclophotocoagulation (CW-TSCPC), and MicroPulse Laser Trabeculoplasty (MLT) are non-incisional treatments that expand ways to

IRIX

2 minute read

Catalyst Pharmaceuticals Announces FDA Approval Of Supplemental New Drug Application For FIRDAPSE Expanding Patient Population To Include Pediatric Patients 6 Years Of Age And Older

By Benzinga Newsdesk

September 29, 11:20 AM

CORAL GABLES, Fla., Sept. 29, 2022 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (NASDAQ:CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and

CPRX

1 minute read

Palisade Bio Announces Oral Presentation Of Phase 2 Data At The American College Of Surgeons Clinical Congress 2022 Oct 17

By Benzinga Newsdesk

September 29, 8:54 AM

Carlsbad, CA, Sept. 29, 2022 (GLOBE NEWSWIRE) -- Palisade Bio, Inc.(NASDAQ:PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today

PALI

2 minute read

SELLAS Life Sciences Presents Poster At 2022 SOHO Meeting Highlighting Bioequivalence Data For GFH009 Formulations

By Benzinga Newsdesk

September 29, 8:36 AM

GFH009 Formulation is Near Physiological pH, While Still Achieving Desired Effect - GFH009 at pH 6.0 Decreased Potential for Infusion Reaction and Made Dosing Better Tolerated After Multiple Doses or Long-time

SLS