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The Latest Breaking News from FDA

FDA halts use of 2 treatments found to be ineffective against omicron

WASHINGTON — U.S. regulators restricted the use of a pair of COVID-19 monoclonal antibody therapies after scientific evidence suggested they are unlikely to be effective against the omicron variant.

Tribune News Service

FDA halts use of antibody drugs that don't work vs. omicron

U.S. health officials say COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they don't work against the omicron variant

The Independent UK

Tango Therapeutics' TNG908 IND For Cancer Study Gets Green Signal By FDA

The

Benzinga

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FDA Clears Lyell Immunopharma' LYL132 Trial For Solid Tumors

The

Benzinga

FDA Gives Nod To TScan Therapeutics' Early-Stage Trial Of TSC-100 In Hematologic Malignancies

The

Benzinga

Ionis' Eplontersen Receives FDA Orphan Drug Status For Misfolded Protein Disorder

The

Benzinga

Soleno Concludes Type C Meeting With FDA For Diazoxide Choline In Prader-Willi Syndrome

Soleno Therapeutics Inc (NASDAQ: SLNO) said that on January 20, 2022, the Company

Benzinga

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Legalisation of household cannabis, limited recreational use

The Food and Drug Administration (FDA) drafted a bill to legalise the household cultivation and consumption of cannabis and its recreational use in some locations.

Bangkok Post

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

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

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Tribune News Service

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.

Birmingham Post

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

Benzinga

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

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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

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

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