FDA Archives - Page 196 of 220

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Jazz Pharmaceuticals Announces Initiation Of Phase 3 Trial Evaluating Epidiolex/Epidyolex For Patients With Epilepsy With Myoclonic-Atonic Seizures

August 18, 7:32 AM

Trial is the first randomized, controlled clinical trial evaluating cannabidiol to treat children and adolescents living with a developmental and epileptic encephalopathy known as Epilepsy with

JAZZ

2 minute read

BD Launches First-in-Human Trial Of Sirolimus Drug-Coated Balloon To Expand Treatment Options For Peripheral Arterial Disease

By Benzinga Newsdesk

August 18, 6:36 AM

BD (Becton, Dickinson and Company) (NYSE:BDX), a leading global medical technology company, has announced the start of enrollment in a first-in-human trial of a peripheral sirolimus drug-coated balloon (DCB). BD is a

BDX

2 minute read

Recap Of Wednesday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

August 17, 6:33 PM

The U.S. Food and Drug Administration (FDA) has approved Bluebird bio’s (NASDAQ:BLUE) lead asset ZYNTEGLO (betibeglogene autotemcel) to treat…

BLUE

3 minute read

Independent Study Shows Cue Health’s Molecular COVID-19 Test is as Accurate as Lab-Based PCR Test

By Benzinga Newsdesk

August 17, 4:23 PM

SAN DIEGO, Calif., Aug. 17, 2022 /PRNewswire/ -- Cue Health Inc. ("Cue") (NASDAQ: HLTH) announced today the preprint publication of an independent clinical study - the largest of itsSAN DIEGO, Calif., Aug. 17, 2022 /PRNewswire/ -- Cue Health Inc.

HLTH

1 minute read

Bluebird’s Gene Therapy Scores US Approval For Genetic Blood Disorder, Probably The Most Expensive

By Vandana Singh

August 17, 3:16 PM

The FDA has approved Bluebird bio Inc’s (NASDAQ:BLUE) Zynteglo (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed for…

BLUE

1 minute read

FDA
News

Bluebird Bio Announces U.S. Commercial Infrastructure To Enable Patient Access To ZYNTEGLO

By Benzinga Newsdesk

August 17, 2:32 PM

Price of ZYNTEGLO reflects potentially curative clinical benefit through achievement of durable transfusion independence and normal or near normal total hemoglobin levels Innovative outcomes-based contract offering

BLUE

3 minute read

Bluebird Bio PR Announces FDA Approval Of ZYNTEGLO

By Bill Haddad

August 17, 2:07 PM

ZYNTEGLO offers potentially curative benefit across ages and genotypes, through the achievement of durable transfusion independence and normal or near normal total hemoglobin levels Management team to host conference

BLUE

1 minute read

Why Eargo Stock Is Rising Today

By Adam Eckert

August 17, 9:44 AM

Eargo Inc (NASDAQ: EAR) shares are trading higher Wednesday after the U.S. Food and Drug Administration on Tuesday issued a final rule to improve access to hearing aids.

EAR

1 minute read

GSK’s Rare Blood Cancer Candidate Goes Under FDA Review

By Vandana Singh

August 17, 8:44 AM

The FDA has accepted GSK plc’s (NYSE:GSK) marketing application for momelotinib, a potential new medicine with a proposed differentiated mechanism of…

GSK

1 minute read

FDA
News

Omeros Corporation Receives Interim Response From FDA On Formal Dispute Resolution Request For Narsoplimab

By Bill Haddad

August 17, 8:41 AM

Omeros Corporation (NASDAQ:OMER) today announced that the United States Food and Drug Administration (FDA) provided an interim response to the company’s formal dispute resolution request submitted to the Agency in

OMER