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The Latest Breaking News from FDA

Cardiovascular Systems, OrbusNeich Scores FDA Approval For Scoreflex Scoring Balloon

Cardiovascular Systems Inc (NASDAQ: CSII), along with OrbusNeich Medical Company Ltd, have

Benzinga

Casi Pharma-Partnered BioInvent's Lead Cancer Program Gets FDA Orphan Drug Tag

The

Benzinga

Aptorum Shares Rise After FDA Orphan Drug Tag For Repurposed Compound For Pediatric Cancer

The FDA has

Benzinga

From analysis to the latest developments in health,
read the most diverse news in one place.

FDA clears Nuvation Bio's IND Application For NUV-868 In Advanced Solid Tumors

The

Benzinga

The Daily Biotech Pulse: Novavax COVID Shot Authorized In Australia, Zymeworks Restructures, Orphan Drug Designation For Marker's Pancreatic Cancer Drug

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

Omeros Submits Response To FDA Regarding Narsoplimab Application In HSCT-TMA

Omeros Corporation (NASDAQ: OMER) has submitted to the FDA its response to Complete Response Letter for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

Benzinga

Marker Therapeutics Stock Gains On FDA Orphan Drug Tag For Second MultiTAA-Cell Therapy For Pancreatic Cancer

The

Benzinga

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52 Biggest Movers From Yesterday

Gainers Zogenix, Inc. (NASDAQ: ZGNX) shares surged 65.7% to close at $25.92 on Wednesday after the company announced it will be acquired by UCB for approximately $1.9 billion.

Benzinga

35 Stocks Moving In Wednesday's Mid-Day Session

Gainers Zogenix, Inc. (NASDAQ: ZGNX) shares jumped 67.1% to $26.15 after the company announced it will be acquired by UCB for approximately $1.9 billion.

Benzinga

Yumanity Shares Fall On FDA Hold On Multidose Trials In Parkinson's Disease

The

Benzinga

The Daily Biotech Pulse: Gamida Gains On Positive Regulatory Development, Orphazyme & ADMA Preannouncements, ImmunityBio & Leap Present Positive Data

Here's a roundup of top developments in the biotech space over the last 24 hours.

Benzinga

Gamida Cell Says Planning To Initiate Rolling BLA Submission For Omidubicel; Full BLA Submission On Track For 1H 2022

Planning to initiate rolling BLA submission for omidubicel following positive Type B meeting with FDA Full BLA submission on track for first half of 2022

Benzinga

FDA warns this brand of at-home Covid test may give false results

Anyone who has used these tests in the past two weeks should re-test to confirm ‘questionable results’

The Independent UK

FDA Approves PolarityTE's Phase 3 Study Of SkinTE In Chronic Cutaneous Ulcer

The

Benzinga

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FDA Grants Fast Track Tags To Drug Candidates For Antares Pharma, Celcuity, Celularity

The

Benzinga

34 Stocks Moving In Tuesday's Mid-Day Session

Gainers NeuroMetrix, Inc. (NASDAQ: NURO) shares gained 37.2% to $6.75 after the company eeceived FDA Breakthrough Device Designation for the treatment of chronic chemo induced peripheral neuropathy with its wearable neurostimulation technology.

Benzinga

NeuroMetrix Shares Rally On FDA Breakthrough Tag For Neurostimulation Device

The

Benzinga

FDA Issues Clinical Hold On Dyne's IND For Duchenne Muscular Dystrophy Program

The

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Benzinga

FDA Pushes Review Period For Bluebird bio's Neurodegenerative Disease, Thalassemia Gene Therapies

The

Benzinga

Psyched: Delix Raises $30M, New Ketamine Study For Alcohol Use Disorder, FDA Approves Ketamine Trial For ALS

New Awakn Study Shows Ketamine Has Potential To Treat Alcoholism

Benzinga

FDA Clears Surgalign's HOLO Portal Surgical Guidance System For Spine Procedures

The

Benzinga

Gilead Withdraws Use Of Zydelig In Two Forms Of Blood Cancer In US

Gilead Sciences Inc (NASDAQ: GILD) recently notified the FDA of its decision to

Benzinga

FDA Gives Back To Back Approval To Pfizer's & AbbVie's JAK Inhibitors For Atopic Dermatitis

Along with AbbVie Inc's (NYSE: ABBV)

Benzinga

FDA Approves AbbVie's Upadacitinib For Refractory Atopic Dermatitis In Patients 12 Years & Older

The

Tribune News Service

FDA: Medtronic slow to update, recall defective insulin pumps for diabetes patients

While the U.S. Food and Drug Administration acknowledges Medtronic is actively working on fixing issues within its diabetes business, especially in regard to some of its insulin pumps, it says the steps took too long and are not enough.

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