FDA

FDA eases review burden for certain sutures, orthopedic devices in leap-frog guidances
RAPS.org
Mon, 04/11/22 - 07:29 pm
FDA
devices
Medtech
regulatory
Orthopedic
Gilead’s CD47 trials freed of FDA hold—for the most part
Fierce Biotech
Mon, 04/11/22 - 07:23 pm
Gilead Sciences
clinical trials
CD47
magrolimab
acute myeloid leukemia
FDA
FDA's Califf on accelerated approval: 'In God, we trust, everyone else must bring good evidence'
Fierce Biotech
Mon, 04/11/22 - 10:41 am
Robert Califf
FDA
accelerated approvals
regulatory
FDA sees 'appropriate' transition period for COVID-19 test EUAs when public health emergency ends
Medtech Dive
Thu, 04/7/22 - 06:03 pm
COVID-19
diagnostics
Medtech
FDA
Emergency Use Authorizations
FDA aims to decide on strain selection for COVID boosters by June
Reuters
Thu, 04/7/22 - 06:01 pm
FDA
COVID-19
vaccines
boosters
FDA proposes to rate pharmaceutical manufacturing facilities
RAPS.org
Thu, 04/7/22 - 05:55 pm
FDA
Office of Pharmaceutical Quality
drug manufacturing
In a one-two gut punch after kidney drug CRL, Akebia slapped with partial hold and will lay off 42% of staff
Endpoints
Thu, 04/7/22 - 10:49 am
Akebia Therapeutics
FDA
vadadustat
layoffs
Abbott’s New Leadless Pacemaker Receives FDA Approval for Slow Heart Rhythms
Xtalks
Thu, 04/7/22 - 10:30 am
Medtech
devices
Abbott Labs
FDA
Aveir
leadless pacemakers
pacemakers
A Win for AI: FDA Approves BioXCel Therapy for Bipolar Disorder and Schizophrenia
BioSpace
Wed, 04/6/22 - 07:47 pm
BioXcel
artificial intelligence
bipolar disorder
schizophrenia
FDA
Igalmi
FDA halts Vir, GSK antibody use in response to COVID subvariant's spread
BioPharma Dive
Wed, 04/6/22 - 12:28 pm
FDA
GSK
Vir Biotechnology
antibodies
COVID-19
Omicron BA.2
Novartis' PI3K drug, already approved in breast cancer, nabs a speedy OK to treat ultra-rare condition
Endpoints
Wed, 04/6/22 - 12:01 pm
Novartis
alpelisib
FDA
RWE
real world evidence
PROs
FDA releases draft guidance for cell and gene therapies
Biopharma Reporter
Wed, 04/6/22 - 11:35 am
FDA
regulatory
cell therapy
gene therapy
CAR-T
User fee reauthorization marches on with first Senate hearing
RAPS.org
Tue, 04/5/22 - 11:38 pm
Senate
regulatory
FDA
user fees
Novartis manufacturing facility in North Carolina gets FDA all-clear to produce, ship gene therapies
Endpoints
Tue, 04/5/22 - 11:33 pm
Novartis
gene therapy
North Carolina
FDA
Zolgensma
Feeling Blue: bluebird bio cuts staff by 30%, prepares for FDA decision
BioSpace
Tue, 04/5/22 - 11:55 am
Bluebird Bio
FDA
layoffs
restructuring
eli-cel
beti-cel
FDA advisory group plans future responses to COVID-19
Medical News Today
Tue, 04/5/22 - 11:16 am
FDA
COVID-19
vaccines
boosters
Califf lays out vision for connected healthcare ecosystem
RAPS.org
Tue, 04/5/22 - 11:09 am
FDA
regulatory
Robert Califf
healthcare reform
FDA accepts Regeneron, Sanofi’s Dupixent for priority review
Pharmaceutical Business Review
Tue, 04/5/22 - 10:53 am
Regeneron
Sanofi
Dupixent
FDA
eosinophilic esophagitis
FDA’s legislative wish list includes device cybersecurity, a generic exclusivity fix, and more
RAPS.org
Mon, 04/4/22 - 11:15 pm
FDA
regulatory
cybersecurity
MDUFA
devices
Medtech
generics
Alnylam's potential fourth RNAi approval delayed three months, but impact likely to be 'modest'
Endpoints
Mon, 04/4/22 - 11:08 pm
Alnylam
RNAi
FDA
vutrisiran

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