FDA

FDA warns AstraZeneca over false advertising of COPD drug
Beckers Hospital Review
Thu, 08/17/23 - 09:52 am
AstraZeneca
COPD
FDA
Breztri Aerosphere
DTC advertising
Bluebird’s Lovo-Cel Gene Therapy for SCD Will Not Face FDA Adcomm
BioSpace
Wed, 08/16/23 - 11:09 pm
Bluebird Bio
sickle cell disease
lovo-cel
FDA
Delcath Gets FDA Approval for Cancer Drug-Device Combo 10 Years After Rejection
BioSpace
Wed, 08/16/23 - 10:21 am
Delcath
drug-device combos
FDA
Hepzato
uveal melanoma
FDA lifts clinical hold on Gilead's CAR-T as Arcellx sheds light on reason for patient death
Fierce Biotech
Tue, 08/15/23 - 10:12 am
Gilead Sciences
Arcellx
CAR-T
cell therapy
FDA
New Alzheimer’s drug raises hopes — along with questions
Medical Marketing and Media
Mon, 08/14/23 - 06:54 pm
FDA
Alzheimer's disease
Eisai
Biogen
Leqembi
FDA approves bispecific drug from Pfizer for multiple myeloma
BioPharma Dive
Mon, 08/14/23 - 06:44 pm
Pfizer
bispecifics
Elrexfio
Multiple Myeloma
FDA
FDA Action Alert: Ipsen, Revance, Neurocrine and Regeneron
BioSpace
Mon, 08/14/23 - 11:29 am
FDA
Ipsen
Revance Therapeutics
Neurocrine
Regeneron
palovarotene
fibrodysplasia ossificans progressiva
Daxxify
cervical dystonia
Ingrezza
chorea
Huntington's disease
pozelimab
CHAPLE disease
J&J joins PARP rivals with narrow FDA clearance in prostate cancer
BioPharma Dive
Mon, 08/14/23 - 10:18 am
JNJ
Akeega
BRCA-mutated prostate cancer
PARP inhibitors
FDA
FDA, seeking time for phase 4 talks, delays decision on Valneva's chikungunya vaccine by 3 months
Fierce Biotech
Mon, 08/14/23 - 10:13 am
Valneva
vaccines
FDA
chikungunya virus
FDA puts 2seventy CAR-T trial on hold in wake of patient death
Fierce Biotech
Mon, 08/14/23 - 10:06 am
2seventy bio
clinical trials
FDA
patient deaths
AML
CAR-T
Median lag between FDA authorization and Medicare coverage hits 6 years: study
Medtech Dive
Sun, 08/13/23 - 02:31 pm
devices
Medtech
FDA
Medicare
Regeneron's high-dose Eylea shows staying power as company awaits FDA decision
Fierce Pharma
Thu, 08/10/23 - 09:49 pm
Regeneron
Eylea
age-related macular degeneration
FDA
Boston Scientific receives FDA approval for cryoablation system
Medtech Dive
Thu, 08/10/23 - 09:47 pm
Boston Scientific
Medtech
FDA
cardiac ablation
cryoablation
atrial fibrillation
POLARx
Galera Lays Off 70% of Staff After FDA Rejection in Severe Oral Mucositis
BioSpace
Thu, 08/10/23 - 11:32 am
Galera Therapeutics
avasopasem manganese
layoffs
oral mucositis
head and neck cancer
FDA
FDA’s OTP Super Office on Track to Fill 500 Positions
BioSpace
Thu, 08/10/23 - 09:59 am
FDA
OTP
CBER
Peter Marks
J&J bags first FDA approval for a GPRC5D drug
Pharmaphorum
Thu, 08/10/23 - 09:52 am
JNJ
FDA
GPRC5D
Talvey
relapsed or refractory multiple myeloma
Novartis prepares for FDA submission for its chronic hives treatment
Clinical Trials Arena
Wed, 08/9/23 - 10:15 am
Novartis
remibrutinib
chronic hives
FDA
Bluebird touts Zynteglo, Skysona launch progress as FDA decision on sickle cell therapy nears
Fierce Pharma
Tue, 08/8/23 - 11:33 am
Bluebird Bio
Zynteglo
Skysona
FDA
sickle cell disease
gene therapy
Biogen, Sage's postpartum depression approval overshadowed by larger rejection
Fierce Pharma
Mon, 08/7/23 - 12:01 pm
SAGE Therapeutics
Biogen
FDA
Zurzuvae
postpartum depression
major depressive disorder
FDA Approves Biogen, Sage’s Zurzuvae as First Pill for Postpartum Depression
BioSpace
Sun, 08/6/23 - 09:39 pm
Biogen
SAGE Therapeutics
FDA
Zurzuvae
postpartum depression
major depressive disorder
zuranolone

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