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» FDA
FDA
Oncology drugmakers seek the sweet spot between efficacy and tolerability
Pharma Voice
Mon, 12/11/23 - 10:16 am
cancer
oncology
drug development
FDA
FDA approves bluebird's sickle cell disease gene therapy. Can Lyfgenia overcome CRISPR's halo?
Fierce Pharma
Sun, 12/10/23 - 11:15 pm
Bluebird Bio
sickle cell disease
FDA
CRISPR
Lyfgenia
In historic decision, FDA approves a CRISPR-based medicine for treatment of sickle cell disease
Stat
Fri, 12/8/23 - 11:36 am
Vertex Pharmaceuticals
FDA
CRISPR
gene editing
Casgevy
sickle cell disease
FDA Could Approve First CRISPR Treatment Today That Might Cure Sickle Cell
Forbes
Fri, 12/8/23 - 09:54 am
Vertex Pharmaceuticals
Casgevy
FDA
CRISPR
sickle cell disease
FDA clears Becton's less-invasive blood collection device
Reuters
Thu, 12/7/23 - 11:55 am
Becton Dickinson
FDA
blood collection
Medtech
Ipsen/Genfit eye June FDA verdict for liver drug elafibranor
Pharmaphorum
Thu, 12/7/23 - 11:01 am
Genfit
Ipsen
elafibranor
primary biliary cholangitis
FDA
priority review
Novartis hit with FDA letter detailing 'significant' Kymriah manufacturing shortfalls
Fierce Pharma
Thu, 12/7/23 - 10:08 am
Novartis
FDA
Kymriah
CAR-T
drug manufacturing
FDA renews Syapse collaboration to use real-world data in oncology
Clinical Trials Arena
Wed, 12/6/23 - 08:53 pm
FDA
oncology
real world data
Syapse
Novartis receives FDA approval for Fabhalta to treat PNH in adults
Pharmaceutical Business Review
Wed, 12/6/23 - 10:25 am
Novartis
FDA
Fabhalta
iptacopan
PNH
paroxysmal nocturnal hemoglobinuria
Humira Biosimilars Not Gaining Traction Epitomizes Dysfunctional U.S. System
Forbes
Mon, 12/4/23 - 10:14 am
Humira
AbbVie
biosimilars
FDA
Lilly Wins Second Accelerated Approval for Reversible BTK Inhibitor
BioSpace
Mon, 12/4/23 - 09:41 am
Eli Lilly
FDA
Jaypirca
CLL
small lymphocytic leukemia
Btk inhibitors
FDA starts review of Padcev/Keytruda for bladder cancer
Pharmaphorum
Fri, 12/1/23 - 09:35 am
Merck
Astellas
Seagen
Padcev
bladder cancer
FDA
priority review
US FDA clears Vivos Therapeutics' oral device for sleep apnea
Reuters
Thu, 11/30/23 - 10:17 am
Medtech
Vivos Therapeutics
obstructive sleep apnea
FDA
BiVACOR wins IDE to start first-in-human study for artificial heart
Clinical Trials Arena
Thu, 11/30/23 - 10:06 am
BiVACOR
FDA
IDE
Medtech
Artificial Heart
FDA names chief scientist Bumpus as Woodcock’s successor
BioPharma Dive
Wed, 11/29/23 - 12:08 pm
FDA
regulatory
Janet Woodcock
Namandjé Bumpus
FDA Launches Probe of Malignancies Linked to CAR-T Therapies
BioSpace
Wed, 11/29/23 - 12:04 pm
CAR-T
side effects
FDA
FDA Rejects Aldeyra’s Dry Eye Drug, Cites Need for Additional Trial
BioSpace
Wed, 11/29/23 - 12:03 pm
Aldeyra Therapeutics
reproxalap
FDA
dry eye disease
FDA kicks off review of Karuna’s schizophrenia drug KarXT
Pharmaphorum
Wed, 11/29/23 - 11:57 am
Karuna
KarXT
FDA
schizophrenia
FDA rebuffs Entrada's attempt to get yearlong hold on DMD drug lifted
Fierce Biotech
Wed, 11/22/23 - 12:03 pm
Entrada Therapeutics
FDA
Duchenne Muscular Dystrophy
ENTR-601-44
NeoImmuneTech receives orphan drug status for NT-I7 to treat ARS
Pharmaceutical Business Review
Tue, 11/21/23 - 11:59 am
NeoImmune Tech
FDA
NT-I7
acute radiation syndrome
orphan drugs
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