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The Latest Breaking News from FDA

Groups seek to shape final rule to ease hearing aid accessibility

WASHINGTON — The Food and Drug Administration is working to finalize a rule that would make it easier for many adults to get hearing aids, a policy change five years in the making that is sparking intense lobbying.

Tribune News Service

Cortexyme Stock Plunges On FDA Hold On Atuzaginstat's IND

The

Benzinga

FDA Approves First T Cell Receptor Therapy From Immunocore For Eye Cancer

The

Benzinga

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The Daily Biotech Pulse: Gilead's Blood Cancer Studies Placed On Partial Clinical Hold, Immunocore Gets FDA Nod, NRx Touts Positive COVID-19 Data

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

Benzinga

MindMed Shares Soar After FDA Approves First Commercial Clinical Trial On LSD In 40 Years

MindMed (NASDAQ: MNMD), a drug development company in the psychedelics space, announced on Tuesday that the FDA has allowed an investigational new drug application for a Phase 2b trial on a proprietary LSD analog.

Benzinga

FDA Puts Clinical Hold On Gilead's Magrolimab/Azacitidine Combo Trials In Blood Cancer Settings

The

Benzinga

Groups seek to shape final rule to ease hearing aid accessibility - Roll Call

President Biden touts the proposal as a way to lower prices, as only 1 in 5 Americans who could benefit from a hearing aid uses one.

Roll Call

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DeSantis blasts FDA for halting drugs ineffective on omicron

Florida Gov. Ron DeSantis has vowed to fight a decision from federal health regulators to block two coronavirus antibody treatments after the drugs were found to be ineffective against treating the widespread omicron variant

The Independent UK

Genentech's Evrysdi Application Under FDA Priority Review For Use In Babies Below 2 Months

The

Benzinga

FDA Guides Annovis Bio For Two Phase 3 Buntanetap Trial In Parkinson's Disease

Annovis Bio Inc (NYSE: ANVS) has

Benzinga

Psychedelic Medicine Co. PharmaTher Provides Update On Pipeline And Milestones For 2022

This article was originally published on Microdose and appears here with permission.

Benzinga

FDA revokes approval for Covid antibody drugs that don’t work against Omicron prompting DeSantis pushback

Florida governor pushes back against decision, calling it ‘sudden and reckless’

The Independent UK

The Daily Biotech Pulse: Pfizer-BioNTech Starts Omicron-Specific Vaccine Study, J&J Misses On Topline, Sierra Oncology Reports Positive Data

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

Benzinga

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FDA Holds Mustang Bio's Gene Therapy IND For Compromised Immune System Disorder

The FDA has

Axios

FDA limits use of Regeneron and Lilly COVID antibody treatments

The FDA said "data show these treatments are highly unlikely to be active" against Omicron.

Benzinga

FDA Rescinds Authorization For Regeneron, Eli Lilly COVID-19 Antibody Treatments: Here's Why

Antibody treatments made by Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Eli Lilly And Co (NYSE: LLY) are not likely to work against the Omicron variant of COVID-19 and their emergency use authorization has been rescin

Tribune News Service

News briefs

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

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Tribune News Service

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.

The Independent UK

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

Benzinga

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

The

Benzinga

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

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