FDA

FDA Questions Efficacy of Merck-AstraZeneca’s Lynparza Ahead of Adcomm
BioSpace
Thu, 04/27/23 - 10:58 pm
Merck
AstraZeneca
FDA
Lynparza
metastatic castration-resistant prostate cancer
Pfizer wins FDA nod for Prevnar 20 pneumonia vaccine in children
Seeking Alpha
Thu, 04/27/23 - 10:56 pm
Pfizer
vaccines
FDA
Prevnar 20
pneumococcal disease
pediatric
FDA approves first oral microbiome therapy Vowst
Fierce Pharma
Thu, 04/27/23 - 11:53 am
Seres Therapeutics
microbiome
Vowst
SER-109
C. difficile
FDA
Why Arbutus Biopharma stock plunged Tuesday
Benzinga
Wed, 04/26/23 - 10:04 am
Arbutus BioPharma
AB-101
FDA
chronic hepatits B
Medtronic diabetes warning letter lifted by FDA
Medtech Dive
Wed, 04/26/23 - 09:53 am
Medtronic
Medtech
diabetes
FDA
FDA approves Biogen and Ionis’ Tofersen for rare genetic form of ALS
Medical Marketing and Media
Tue, 04/25/23 - 10:20 pm
Biogen
Ionis Pharmaceuticals
ALS
tofersen
FDA
Florida continues to tangle with the FDA over drug importation
WUSF Florida
Tue, 04/25/23 - 10:02 pm
Florida
legal
FDA
drug imporation
Medtronic wins FDA approval for long-delayed MiniMed 780G insulin pump
Medtech Dive
Tue, 04/25/23 - 11:38 am
Medtronic
FDA
Medtech
MiniMed 780G
insulin pumps
diabetes
After 20-month hold, FDA drops resistance to fecal pooling, clears MaaT to run pivotal trial
Fierce Biotech
Tue, 04/25/23 - 10:37 am
MaaT Pharma
FDA
clinical trials
fecal therapy
graft vs host disease
FDA Presses Pause on Another Foghorn Program
BioSpace
Tue, 04/25/23 - 10:31 am
Foghorn Therapeutics
FDA
FHD-609
QTc
Bluebird Bio submits BLA for sickle cell disease gene therapy
Biopharma Reporter
Mon, 04/24/23 - 11:39 am
Bluebird Bio
sickle cell disease
lovo-cel
FDA
CBER to Launch Operation Warp Speed for Rare Diseases by Year’s End
BioSpace
Mon, 04/24/23 - 11:36 am
CBER
Operation Warp Speed
FDA
Rare Diseases
FDA again delays Daiichi's plans to challenge Astellas and Novartis for blood cancer market
Fierce Biotech
Fri, 04/21/23 - 10:08 am
Daiichi Sankyo
Astellas
Novartis
quizartinib
FDA
blood cancer
After pandemic delays, FDA still struggling to inspect foreign drug manufacturers
Medical Marketing and Media
Thu, 04/20/23 - 11:49 pm
FDA
regulatory
foreign drug inspections
FDA warns diagnostic maker for failing to seek approval for changes, OTC firm for lax investigations
RAPS.org
Thu, 04/20/23 - 11:42 pm
FDA
diagnostics
warning letters
Medtech
Abbott Labs
Abbott Point of Care
Zermat
Califf seeks new authorities to approve opioids, mum on mifepristone
RAPS.org
Thu, 04/20/23 - 11:38 pm
FDA
Robert Califf
opioids
mifepristone
FDA Green Lights Roche's Polivy in First-Line DLBCL
BioSpace
Thu, 04/20/23 - 10:45 am
Roche
Genentech
Polivy
diffuse large B-cell lymphoma
FDA
FDA’s new plan to study opioids’ effectiveness faces resistance
Stat
Wed, 04/19/23 - 09:43 pm
FDA
opioids
chronic pain
FDA amends COVID vaccine EUAs, considers animal studies to accelerate updates
RAPS.org
Tue, 04/18/23 - 10:22 pm
FDA
regulatory
COVID-19
vaccines
MRNA
FDA cites Lupin for lax oversight of equipment breakdowns, poor follow up and more
RAPS.org
Tue, 04/18/23 - 10:20 pm
Lupin
FDA
India
drug manufacturing

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