FDA - Spark Newswire

4 minute read

FDA
News

Equillium Reports Topline Results From EQUATE Study In First-Line Treatment Of Acute Graft-Versus-Host Disease

June 11, 7:03 AM

Itolizumab continues to demonstrate favorable safety and efficacy profile Rapid and durable responses resulted in clinically meaningful reduction in corticosteroid use Data support clinical advancement of itolizumab in

1 minute read

European Medicines Agency Gives Update On Evaluation Of COVID-19 Vaccine Plus Myocarditis, Pericarditis Cases: Notes Cases Of Myocarditis And/Or Pericarditis Were Also Reported In Europe Following Vaccination With All COVID-19 Vaccines

By Benzinga Newsdesk

June 11, 6:52 AM

-Reuters

BNTX

1 minute read

FDA
News

Brazilian Health Regulator, Anvisa, Approves Use Of Pfizer COVID-19 Vaccine For Children 12+

By Benzinga Newsdesk

June 11, 6:41 AM

-Reuters

EWZ

3 minute read

FDA
News

Novan Reports Topline Results From Pivotal Phase 3 Trial Of SB206 In Patients With Molluscum Contagiosum: Achieves Statistical Significance, No Serious Adverse Events Reported

By Benzinga Newsdesk

June 11, 6:32 AM

– B-SIMPLE4 achieves statistical significance for the primary endpoint with p-value less than 0.0001 – – No serious adverse events related to treatment with SB206 – – Novan intends to

NOVN

3 minute read

FDA
News

Mustang Bio Offers Interim Phase 1/2 Data For MB-106 CD20-Targeted CAR T In Patients With Relapsed, Refractory B-Cell Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia: 93% overall response rate and 67% complete response rate

By Benzinga Newsdesk

June 11, 6:31 AM

Data presented at the European Hematology Association 2021 Virtual Congress show favorable safety profile and compelling clinical activity 93% overall response rate and 67% complete response rate in patients treated

MBIO

1 minute read

Despite Hitting Mid-Stage Trial Endpoint Goal, Vertex Strikes Out Rare Lung Disease Candidate; Stock Tumbles

By Vandana Singh

June 11, 6:23 AM

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) announced the Phase 2 data evaluating VX-864 in alpha-1 antitrypsin deficiency (AATD) with the PiZZ genotype.

VRTX

2 minute read

FDA
News

Editas Medicine Highlights Presentation Of Preclinical Data Supporting Initiation Of EDIT-301 Phase 1/2 RUBY Trial For Treatment Of Sickle Cell Disease At European Hematology Association Congress

By Benzinga Newsdesk

June 11, 6:01 AM

Preclinical data demonstrated robust fetal hemoglobin (HbF) induction in erythroid progeny cells with no detection of off-target editing; cells showed reduced sickling and improved rheological behavior RUBY trial of

EDIT

1 minute read

Why Did Orphazyme (ORPH) Shares Skyrocket As Much As 1387% Today?

By Shivdeep Dhaliwal

June 10, 10:23 PM

Orphazyme A/S (NASDAQ: ORPH) shares skyrocketed over 300% in the regular session on Thursday. What Happened: Shares of the Denmark-based biopharmaceutical firm touched an intraday high of $77.77, running up 1,387%.

ORPH

2 minute read

FDA
News

Gilead Sciences Says FDA Approved New Formulation Of Epclusa, Expanding Pediatric Indication To Treat Children Ages 3 And Older With Chronic Hepatitis C

By Benzinga Newsdesk

June 10, 5:02 PM

Gilead Sciences, Inc. (NASDAQ:GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the pediatric indication of Epclusa® (sofosbuvir/velpatasvir) for the treatment

GILD