FDA

FDA clears GE Healthcare AI algorithm for patient intubation
Pharmaforum
Wed, 11/17/21 - 10:24 am
FDA
GE Healthcare
artificial intelligence
intubation
devices
Medtech
Pfizer to file for emergency authorization Tuesday for its Covid-19 pill
Stat
Tue, 11/16/21 - 10:43 pm
Pfizer
antivirals
Paxlovid
FDA
COVID-19
FDA Is Back in the Driver’s Seat with LDTs
Medical Devices and Diagnostics Industry
Tue, 11/16/21 - 10:32 pm
FDA
HHS
COVID-19
diagnostics
LDTs
5 things to know about FDA chief nominee Dr. Robert Califf
Beckers Hospital Review
Mon, 11/15/21 - 11:53 pm
FDA
regulatory
Robert Califf
Apellis' eye med application on track for next year after FDA OKs inclusion of phase 2 data
Fierce Pharma
Mon, 11/15/21 - 11:51 pm
Apellis Pharmaceuticals
pegcetacoplan
FDA
clinical trials
age-related macular degeneration
FDA approves PharmaEssentia interferon drug for a rare type of blood cancer
MedCity News
Mon, 11/15/21 - 11:44 pm
PharmaEssentia
FDA
interferon
blood cancers
polycythemia vera
ropeginterferon alfa
Philips sinks beneath the foam
EP Vantage
Mon, 11/15/21 - 12:32 pm
Philips
devices
Medtech
FDA
ventilators
BioMarin's new launch Voxzogo could surprise investors and become a blockbuster brand: analyst
Fierce Pharma
Mon, 11/15/21 - 12:24 pm
Biomarin
FDA
Voxzogo
dwarfism
A couple months ahead of its PDUFA data, Bristol Myers rolls out long-term data for mavacamten
Endpoints
Sat, 11/13/21 - 09:57 pm
Bristol Myers Squibb
FDA
mavacamten
MyoKardia
Biden picks former FDA chief Califf to again lead agency
AP
Fri, 11/12/21 - 11:36 am
FDA
Robert Califf
Joe Biden
Boehringer-Lilly’s Jardiance obtains FDA priority review to treat heart failure
Pharmaceutical Business Review
Fri, 11/12/21 - 10:37 am
Eli Lilly
Boehringer Ingelheim
Jardiance
priority review
FDA
heart failure
How Serious Are Moderna's FDA Delays?
Motley Fool
Fri, 11/12/21 - 10:36 am
FDA
Moderna Therapeutics
COVID-19
vaccines
pediatric
CPhI: As Covid-19 restrictions ease, an inspection backlog could have a big effect on new drugs, generics
Endpoints
Thu, 11/11/21 - 11:09 am
CPhI
pandemic
FDA
regulatory
COVID-19
inspections
generics
Novavax asks for FDA meeting after first global authorization for COVID-19 vaccine: CEO
Yahoo Finance
Thu, 11/11/21 - 11:01 am
Novavax
vaccines
FDA
COVID-19
Stanley Erck
Pharma CEOs
AstraZeneca, FibroGen hope to keep their roxadustat dream alive with new FDA meeting
Fierce Pharma
Wed, 11/10/21 - 10:42 am
FibroGen
AstraZeneca
anemia
roxadustat
FDA
Accelerated approvals under fire again as pivotal trials typically take about as long as confirmatory trials, research shows
Endpoints
Tue, 11/9/21 - 11:46 pm
FDA
accelerated approvals
confirmatory trials
Robotics startup Vicarious files pre-submission with FDA, fresh from $425M SPAC raise
Medtech Dive
Tue, 11/9/21 - 10:30 am
devices
Medtech
robotic surgery
Vicarious Surgical
SPACs
FDA
GSK pulls off clean sweep of endpoint hits in anemia phase 3, positioning it to leapfrog AstraZeneca
Fierce Biotech
Mon, 11/8/21 - 10:47 am
GSK
chronic kidney disease
cliincal trials
FDA
AstraZeneca
anemia
erythropoietin
FibroGen
Ardelyx Prepares for Battle with FDA Over Rejected CKD Drug
BioSpace
Sun, 11/7/21 - 10:47 pm
Ardelyx
chronic kidney disease
tenapanor
FDA
How Will FDA Approval of COVID Vaccines in Younger Kids Impact Pfizer?
Motley Fool
Fri, 11/5/21 - 09:51 am
Pfizer
vaccines
COVID-19
FDA
pediatric

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