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clinical hold

FDA placed hold on Fulcrum's sickle cell therapy over hematological malignancy concerns

FDA placed hold on Fulcrum's sickle cell therapy over hematological malignancy concerns

Fierce Biotech

Fulcrum Therapeutics

sickle cell therapy

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FDA Partially Halts Sanofi’s BTK Inhibitor for Multiple Sclerosis, Myasthenia Gravis

FDA Partially Halts Sanofi’s BTK Inhibitor for Multiple Sclerosis, Myasthenia Gravis

Pharma Live

multiple sclerosis

myasthenia gravis

clinical trials

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FDA lifts hold on Ocugen's COVID-19 vaccine trial. But is it too late for the shot?

FDA lifts hold on Ocugen's COVID-19 vaccine trial. But is it too late for the shot?

Fierce Pharma

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FDA tells Praxis it can't move into the clinic just yet for a rare epilepsy drug

FDA tells Praxis it can't move into the clinic just yet for a rare epilepsy drug

Endpoints

Praxis Precision Medicines

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FDA slaps hold on Finch's C. diff med to get info on COVID-19 screening for donor-derived therapy

FDA slaps hold on Finch's C. diff med to get info on COVID-19 screening for donor-derived therapy

Fierce Biotech

Finch Therapeutics

clinical trials

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Another phenylketonuria hold, courtesy of Homology

Another phenylketonuria hold, courtesy of Homology

EP Vantage

Homology Medicines

clinical trials

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FDA grounds BioMarin gene therapy trial for months with demand for tumor risk data

FDA grounds BioMarin gene therapy trial for months with demand for tumor risk data

Fierce Biotech

clinical trials

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Larimar kept in limbo as FDA maintains clinical hold on leading candidate

Larimar kept in limbo as FDA maintains clinical hold on leading candidate

Fierce Biotech

Larimar Therapeutics

Friedreich's Ataxia

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Legend's early-stage CAR-T on FDA hold after single patient dosed

Legend's early-stage CAR-T on FDA hold after single patient dosed

Fierce Biotech

clinical trials

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Denali Receives Formal Letter Regarding FDA Hold On Alzheimer's Potential Program

Denali Receives Formal Letter Regarding FDA Hold On Alzheimer's Potential Program

Benzinga

Denali Therapeutics

Alzheimer's disease

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Gilead's CD47 clinical hold expands as CEO O'Day expresses 'sense of urgency' in getting trials back on track

Gilead's CD47 clinical hold expands as CEO O'Day expresses 'sense of urgency' in getting trials back on track

Fierce Biotech

Gilead Sciences

clinical trials

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TG slips out a nasty surprise for investors

TG slips out a nasty surprise for investors

EP Vantage

TG Therapeutics

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Gilead's $4.9B oncology bet hit with partial clinical hold, forcing pause of pivotal trials and raising doubts about CD47

Gilead's $4.9B oncology bet hit with partial clinical hold, forcing pause of pivotal trials and raising doubts about CD47

Fierce Biotech

Gilead Sciences

clinical trials

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FDA slaps a hold on Gilead's injectable HIV treatment over concerns about potential glass contaminants

FDA slaps a hold on Gilead's injectable HIV treatment over concerns about potential glass contaminants

Endpoints

Gilead Sciences

clinical trials

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bluebird bio Announces Partial Clinical Hold for Patients Under 18 in Sickle Cell Gene Therapy Clinical Program

bluebird bio Announces Partial Clinical Hold for Patients Under 18 in Sickle Cell Gene Therapy Clinical Program

Yahoo Finance

sickle cell disease

clinical trials

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FDA slaps clinical hold on AstraZeneca cancer drug amid heart safety scare in combo test

FDA slaps clinical hold on AstraZeneca cancer drug amid heart safety scare in combo test

Fierce Biotech

clinical trials

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Aprea gets 2nd clinical hold in a week, this time for lymphoid malignancy study

Aprea gets 2nd clinical hold in a week, this time for lymphoid malignancy study

Fierce Biotech

Aprea Therapeutics

lymphoid leukemia

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Bluebird bio Takes Hit with FDA Clinical Hold on Gene Therapy

Bluebird bio Takes Hit with FDA Clinical Hold on Gene Therapy

BioSpace

cerebral adrenoleukodystrophy

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Magenta Down After FDA Places Clinical Hold on IND for AML/MDS Drug

Magenta Down After FDA Places Clinical Hold on IND for AML/MDS Drug

BioSpace

Magenta Therapeutics

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Large differences in phase 3 overall survival spark FDA hold on Oncopeptides' multiple myeloma drug

Large differences in phase 3 overall survival spark FDA hold on Oncopeptides' multiple myeloma drug

Fierce Biotech

clinical trials

Multiple Myeloma

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