FDA Archives - Page 68 of 220

2 minute read

Sangamo Therapeutics Receives U.S. FDA Fast Track Designation For Isaralgagene Civaparvovec For The Treatment Of Fabry Disease

May 22, 8:06 AM

Sangamo Therapeutics, Inc. (NASDAQ:SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to isaralgagene civaparvovec, or ST-920, a wholly

SGMO

4 minute read

Abbott Unveils Late-Breaking Data Showing The World’s First Dual-Chamber Leadless Pacemaker Study Met All Three Primary Safety And Performance Endpoints; To Present On May 19-21 At The Heart Rythm Society Annual Meeting

By Benzinga Newsdesk

May 20, 3:45 PM

Abbott's AVEIR™ DR i2i™ IDE study is the industry's first prospective study on the safety and performance of the world's first dual-chamber leadless pacemakerThe study successfully met all three of its

ABT

1 minute read

As CorMedix’s DefenCath Moves Forward On Regulatory Path, Analyst Boosts Price Target

By Vandana Singh

May 19, 2:09 PM

Tuesday, CorMedix Inc (NASDAQ: CRMD) resubmitted New Drug Application for DefenCath to the FDA, and the submission has been acknowledged as

CRMD

1 minute read

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Krystal Biotech Receives FDA Approval For First-Ever Redosable Gene Therapy, VYJUVEK For Treatment Of Dystrophic Epidermolysis Bullosa

By Benzinga Newsdesk

May 19, 2:04 PM

Dystrophic Epidermolysis Bullosa (DEB) is a serious rare genetic disease that affects the skin and mucosal tissues and is caused by one or more mutations in the COL7A1 gene, resulting in lack of production of

KRYS

1 minute read

FDA Approves AbbVie/Genmab’s Cancer Drug As First Bispecific Antibody For Type Of Lymphoma In Adult Patients

By Vandana Singh

May 19, 1:59 PM

The FDA has approved Epkinly (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or

ABBV

1 minute read

Stereotaxis, Abbott Ink Pact To Combine Mapping & Robotic Tech: FDA Approves Abbott’s Next-Gen Abalation Catheter

By Vandana Singh

May 19, 1:23 PM

Stereotaxis Inc (NYSE: STXS) shares are gaining after the company announced a global collaboration with Abbott Laboratories (NYSE: ABT) to integrate Abbott's EnSite X EP System with Stereotaxis' <

ABT

2 minute read

EPKINLY Approved By U.S. FDA As The First And Only Bispecific Antibody To Treat Adult Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma

By Benzinga Newsdesk

May 19, 12:37 PM

AbbVie (NYSE:ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLYTM (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the treatment of adult patients

ABBV

2 minute read

Abbott Receives FDA Approval For TactiFlex Ablation Catheter For Treatment Of Abnormal Heart Rhythm

By Happy Mohamed

May 19, 9:03 AM

TactiFlex™ Ablation Catheter, Sensor Enabled™, is the world's first ablation catheter designed with a unique flexible electrode tip and contact force sensing to treat patients with atrial

ABT

1 minute read

FDA Votes In Favor Of Pfizer’s Maternal RSV Vaccine To Prevent Disease In Infants

By Vandana Singh

May 19, 9:00 AM

The U.S.

PFE

1 minute read

The First Test To Detect Preeclampsia From Thermo Fisher Gets FDA Approval

By Vandana Singh

May 19, 8:59 AM

The FDA has reportedly approved Thermo Fisher Scientific Inc's (NYSE: TMO) blood test for preeclampsia, which causes pregnancy-related illness and death, to aid in the risk assessment of pregnant women

TMO