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The Latest Breaking News from FDA

DeSantis still won’t say if he’s had booster after Trump accused politicians of being ‘gutless’ for secrecy

Donald Trump and Ron DeSantis, both 2024 frontrunners, have traded barbs in recent weeks

The Independent UK

Neuralink is gearing up for human trials despite lacking FDA approval

Elon Musk's brain-computer interface company still hasn't been given the go-ahead to test its implants on humans.

Input

Ask the Doctors: New FDA guidance asks food manufacturers to cut salt in their products

It’s targeting food manufacturers, restaurants and other vendors of prepared foods in an effort to help reduce how much sodium Americans consume.

Chicago Sun-Times

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The Daily Biotech Pulse: Kura Lifts Clinical Hold On Blood Cancer Trial, Intuitive Surgical Earnings, Sorrento's Omicron Antibody Treatment Effective

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

Benzinga

Elanco's Long-Acting Transdermal Buprenorphine for Cats Gains FDA Approval

The

Benzinga

FDA Lifts Partial Hold On Kura Oncology's Early-Stage Leukemia Trial

The

Benzinga

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

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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

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

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

The

Benzinga

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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.

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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

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

Benzinga

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

The

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