clinical hold

FDA placed hold on Fulcrum's sickle cell therapy over hematological malignancy concerns
Fierce Biotech
Thu, 03/9/23 - 11:43 am
FDA
Fulcrum Therapeutics
sickle cell therapy
FDX-6058
clinical hold
FDA Partially Halts Sanofi’s BTK Inhibitor for Multiple Sclerosis, Myasthenia Gravis
Pharma Live
Thu, 06/30/22 - 10:59 am
Sanofi
multiple sclerosis
myasthenia gravis
FDA
tolebrutinib
clinical trials
clinical hold
FDA lifts hold on Ocugen's COVID-19 vaccine trial. But is it too late for the shot?
Fierce Pharma
Mon, 05/23/22 - 10:14 am
Ocugen
FDA
clinical hold
vaccines
COVID-19
Covaxin
FDA tells Praxis it can't move into the clinic just yet for a rare epilepsy drug
Endpoints
Fri, 04/29/22 - 10:45 am
Praxis Precision Medicines
FDA
clinical hold
epilepsy
PRAX-222
FDA slaps hold on Finch's C. diff med to get info on COVID-19 screening for donor-derived therapy
Fierce Biotech
Thu, 03/3/22 - 10:21 am
Finch Therapeutics
C. difficile
clinical hold
FDA
clinical trials
microbiome
Another phenylketonuria hold, courtesy of Homology
EP Vantage
Tue, 02/22/22 - 10:43 am
Homology Medicines
HMI-102
Biomarin
BMN 307
FDA
clinical trials
clinical hold
PKU
FDA grounds BioMarin gene therapy trial for months with demand for tumor risk data
Fierce Biotech
Fri, 02/18/22 - 10:32 am
Biomarin
FDA
clinical trials
clinical hold
BMN 307
PKU
gene therapy
Larimar kept in limbo as FDA maintains clinical hold on leading candidate
Fierce Biotech
Tue, 02/15/22 - 10:21 am
Larimar Therapeutics
Friedreich's Ataxia
FDA
clinical hold
CTI-1601
Legend's early-stage CAR-T on FDA hold after single patient dosed
Fierce Biotech
Tue, 02/15/22 - 10:15 am
Legend Biotech
CAR-T
FDA
clinical trials
clinical hold
LB1901
Denali Receives Formal Letter Regarding FDA Hold On Alzheimer's Potential Program
Benzinga
Mon, 02/14/22 - 11:00 am
Denali Therapeutics
FDA
DNL919
clinical hold
Alzheimer's disease
Gilead's CD47 clinical hold expands as CEO O'Day expresses 'sense of urgency' in getting trials back on track
Fierce Biotech
Wed, 02/2/22 - 12:15 pm
Gilead Sciences
clinical trials
clinical hold
magrolimab
AML
MDS
TG slips out a nasty surprise for investors
EP Vantage
Mon, 01/31/22 - 10:40 am
TG Therapeutics
FDA
CLL
clinical hold
Gilead's $4.9B oncology bet hit with partial clinical hold, forcing pause of pivotal trials and raising doubts about CD47
Fierce Biotech
Wed, 01/26/22 - 11:12 am
Gilead Sciences
magrolimab
anti-CD47
FDA
clinical trials
oncology
clinical hold
FDA slaps a hold on Gilead's injectable HIV treatment over concerns about potential glass contaminants
Endpoints
Wed, 12/22/21 - 11:01 am
Gilead Sciences
FDA
HIV
lenacapavir
clinical trials
clinical hold
bluebird bio Announces Partial Clinical Hold for Patients Under 18 in Sickle Cell Gene Therapy Clinical Program
Yahoo Finance
Mon, 12/20/21 - 10:54 am
Bluebird Bio
lovo-cel
gene therapy
sickle cell disease
FDA
clinical hold
clinical trials
FDA slaps clinical hold on AstraZeneca cancer drug amid heart safety scare in combo test
Fierce Biotech
Wed, 10/20/21 - 06:54 pm
AstraZeneca
clinical trials
FDA
clinical hold
AZD5991
AML
Aprea gets 2nd clinical hold in a week, this time for lymphoid malignancy study
Fierce Biotech
Thu, 08/12/21 - 11:20 am
Aprea Therapeutics
FDA
clinical hold
eprenetapopt
lymphoid leukemia
Bluebird bio Takes Hit with FDA Clinical Hold on Gene Therapy
BioSpace
Mon, 08/9/21 - 11:48 pm
Bluebird Bio
FDA
clinical hold
gene therapy
eli-cel
cerebral adrenoleukodystrophy
Magenta Down After FDA Places Clinical Hold on IND for AML/MDS Drug
BioSpace
Wed, 07/21/21 - 08:41 pm
Magenta Therapeutics
AML
MDS
FDA
clinical hold
MGTA-117
Large differences in phase 3 overall survival spark FDA hold on Oncopeptides' multiple myeloma drug
Fierce Biotech
Thu, 07/8/21 - 11:06 am
Oncopeptides
melflufen
clinical trials
FDA
clinical hold
Multiple Myeloma

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