FDA

FDA Blocks Mesoblast Cell Therapy Again, Asks for More Data
BioSpace
Sun, 08/6/23 - 09:34 pm
Mesoblast
remestemcel-L
FDA
graft vs host disease
cell therapy
Iveric drug approved for type of vision loss as rival’s safety draws scrutiny
BioPharma Dive
Sun, 08/6/23 - 09:25 pm
Iveric Bio
geographic atrophy
FDA
Izervay
Astellas
FDA rejects Mesoblast's cell therapy for bone marrow transplant complications
Yahoo/Reuters
Fri, 08/4/23 - 12:07 pm
Mesoblast
FDA
cell therapy
bone marrow transplants
remestemcel-L
Regeneron expects FDA decision on higher-dose Eylea this year
Reuters
Thu, 08/3/23 - 06:40 pm
Regeneron
Eylea
FDA
FDA Clears Taiho’s Lonsurf in Metastatic Colorectal Cancer Ahead of Takeda, Hutchmed
BioSpace
Thu, 08/3/23 - 10:23 am
Taiho Oncology
Lonsurf
colorectal cancer
FDA
Takeda
Hutchmed
DEA, FDA outline steps to mitigate ADHD drug shortage
The Hill
Tue, 08/1/23 - 10:30 pm
DEA
FDA
ADHD
drug shortages
GSK beats Merck to first PD-1 approval in newly diagnosed endometrial cancer
Fierce Pharma
Mon, 07/31/23 - 09:59 pm
GSK
FDA
immunotherapy
endometrial cancer
Jemperli
Vivek Ramaswamy wants to ‘gut’ the FDA
Stat
Mon, 07/31/23 - 09:48 pm
Vivek Ramaswamy
2024 Presidential election
FDA
Roivant Sciences
After quitting FDA adcomm in protest of Aduhelm decision, Harvard's Aaron Kesselheim finds agency has an approval bias
Fierce Pharma
Mon, 07/31/23 - 10:07 am
FDA
Biogen
Aduhelm
Alzheimer's disease
advisory committees
drug approvals
FDA Action Alert: Mesoblast, Sage/Biogen and Galera
BioSpace
Mon, 07/31/23 - 10:05 am
FDA
graft vs host disease
head and neck cancer
postpartum depression
major depressive disorder
Mesoblast
remestemcel-L
Biogen
SAGE Therapeutics
zuranolone
Galera Therapeutics
avasopasem manganese
FDA CBER Chief Marks overrules staff drug reviewers 'with trepidation'
Fierce Biotech
Sat, 07/29/23 - 10:50 pm
FDA
Peter Marks
CBER
drug reviews
Go or no go? Biogen and Astellas head towards key PDUFAs
EP Vantage
Sat, 07/29/23 - 10:45 pm
FDA
Astellas
Zimura
Biogen
SAGE Therapeutics
zuranolone
major depressive disorder
postpartum depression
geographic atrophy
Further blow for Biohaven as FDA refuses to consider failed rare disease drug for approval
Fierce Biotech
Thu, 07/27/23 - 10:19 am
Biohaven
FDA
troriluzole
Octapharma secures FDA nod for warfarin reversal agent Balfaxar
Fierce Pharma
Wed, 07/26/23 - 06:43 pm
Octapharma
FDA
bloodthinner reversals
Balfaxar
FDA clears Tarsus' Xdemvy as first treatment for common eyelid disease
Fierce Pharma
Tue, 07/25/23 - 08:58 pm
Tarsus Pharmaceuticals
Xdemvy
FDA
Demodex blepharitis
FDA approves Emergent BioSolutions' anthrax vaccine
Reuters
Fri, 07/21/23 - 11:46 am
Emergent BioSolutions
vaccines
anthrax
FDA
FDA okays Daiichi Sankyo’s Vanflyta for first-line AML
Pharmaphorum
Fri, 07/21/23 - 10:08 am
Daiichi Sankyo
Vanflyta
FDA
AML
After winning full FDA nod for Leqembi, Eisai touts 'promising' study on subcutaneous version
Fierce Pharma
Thu, 07/20/23 - 10:09 am
Eisai
Biogen
Leqembi
FDA
Alzheimer's disease
subcutaneous drug delivery
FDA Approves Sanofi and AstraZeneca’s RSV Antibody for Newborns, Infants
BioSpace
Mon, 07/17/23 - 07:00 pm
Sanofi
AstraZeneca
Beyfortus
nirsevimab
RSV
infants
pediatric
FDA
Astellas' Zolbetuximab Is a Promising Therapy for HER2-Negative Gastric Cancer
Xtalks
Mon, 07/17/23 - 06:54 pm
Astellas
zolbetuximab
gastric cancer
FDA
EMA

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