FDA Archives - Page 166 of 220

1 minute read

Clovis Oncology Announces TRITON3 Phase 3 Trial Of Rubraca Achieves Primary Endpoint In Men With Metastatic Castration-Resistant Prostate Cancer With BRCA Or ATM Mutations

October 3, 7:07 AM

TRITON3 study evaluating Rubraca monotherapy versus chemotherapy or second-line androgen deprivation therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) with mutations in BRCA or ATM

CLVS

4 minute read

AstraZeneca-Merck’s Prostate Cancer Combo Drug, 3rd Try For scPharma, 3 FDA Panel Decisions And More: October’s Key PDUFA Catalysts Biotech Investors Must Know

By Shanthi Rexaline

October 2, 9:49 AM

Most FDA decisions scheduled for September yielded positive results, but there were stray disappointments as well. Seven new molecular entities, or NMEs, were approved during the month, taking the total NME approvals for the year to 24. This is far less than the 40 approvals received by the same time last year.

ALNY

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

By Benzinga Newsdesk

September 30, 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

September 30, 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

September 30, 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

September 30, 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

September 30, 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