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The Latest Breaking News from FDA

Elon Musk’s brain implant company is inching toward human trials

Elon Musk’s brain implant company Neuralink is now hiring a clinical trial director, an indication that the company’s longstanding goal of implanting chips in human brains is coming closer.

Tribune News Service

Tech pioneer PolyPhotonix secures $10m investment to take sight-saving masks into US market

Prevail Partners LLC has agreed to invest significantly in NETPark based PolyPhotonix

Birmingham Post

FDA Clears Turning Point's IND For Elzovantinib + Aumolertinib Combo Regime In Lung Cancer Setting

The

Benzinga

From analysis to the latest developments in health,
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FDA Gives Green Signal To Compass Therapeutics' Mid-Stage Biliary Tract Cancer Trial In US

The

Benzinga

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

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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

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

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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

The Independent UK

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’

Benzinga

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

The

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Benzinga

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

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

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