FDA

Ex-FDA commissioner heads up Flagship Pioneering spinout
Bizjournals
Wed, 12/8/21 - 10:43 am
Stephen Hahn
FDA
Harbinger Health
Flagship Pionnering
Thermo Fisher, Verily on FDA list of COVID-19 tests affected by omicron variant
Medtech Dive
Tue, 12/7/21 - 10:58 am
Medtech
diagnostics
FDA
COVID-19
Omicron COVID-19 variant
Verily
Thermo Fisher
VBI Vaccines Gets FDA Approval for First Three-Antigen Hepatitis B Shot
Xtalks
Tue, 12/7/21 - 10:46 am
VBI Vaccines
FDA
hepatitis B
vaccines
PreHevbrio
US to accelerate authorization of COVID-19 vaccines redesigned for omicron
Beckers Hospital Review
Mon, 12/6/21 - 11:35 pm
FDA
COVID-19
vaccines
Omicron COVID-19 variant
Infants, kids now have a Covid-19 therapy as FDA expands use of Eli Lilly drug
MedCity News
Sun, 12/5/21 - 10:39 pm
Eli Lilly
FDA
COVID-19
pediatric
antibodies
Accelerated approval reforms need meaningful confirmatory trial improvements, professors write in Science
Endpoints
Fri, 12/3/21 - 10:34 am
FDA
accelerated approvals
confirmatory trials
FDA expands eSTAR filing to de novo devices, IVDs
RAPS.org
Thu, 12/2/21 - 10:56 pm
devices
FDA
regulatory
de novo pathway
eSTAR
FDA turns down BeyondSpring chemo complication drug, asks for another trial
Fierce Pharma
Wed, 12/1/21 - 11:48 pm
BeyondSpring
FDA
small molecule drugs
plinabulin
FDA grants priority review to AstraZeneca’s sNDA for breast cancer therapy
Pharmaceutical Business Review
Wed, 12/1/21 - 10:21 am
FDA
AstraZeneca
Lynparza
BRCA-mutant breast cancer
Go or no go? Argenx's December showdown
EP Vantage
Wed, 12/1/21 - 10:10 am
FDA
Argenx
efgartigimod
myasthenia gravis
Calliditas
Nefcon
Merck
Keytruda
FDA panel narrowly recommends authorization of first antiviral pill to treat Covid-19
Stat
Tue, 11/30/21 - 11:35 pm
FDA
Merck
Ridgeback Biotherapeutics
antivirals
COVID-19
molnupiravir
FDA cancels ODAC meeting this week to review two more dangling accelerated approvals — but won't explain why
Endpoints
Tue, 11/30/21 - 11:32 pm
FDA
ODAC
cancer
accelerated approvals
Secura Bio
Acrotech Biopharma
Olema Pharmaceuticals (OLMA) Says Falsified Information is Circulating on Social Media
Street Insider
Tue, 11/30/21 - 10:37 am
Olema Pharmaceuticals
Olema Oncology
social media
FDA
breast cancer OP-1250
ImmunoGen lines up FDA filing as antibody-drug conjugate shrinks tumors in pivotal trial
Fierce Biotech
Tue, 11/30/21 - 10:29 am
Immunogen
mirvetuximab soravtansine
ovarian cancer
FDA
antibody-drug conjugate
Sigilon Uncovers Possible Reason Behind Hemophilia A Trial Hold
BioSpace
Tue, 11/30/21 - 10:28 am
Siglion Therapeutics
cell therapy
FDA
hemophilia A
SIG-001
Like the flu vaccine every year, the FDA could move quickly on a variant-targeted Covid vaccine
Endpoints
Mon, 11/29/21 - 11:11 am
FDA
vaccines
COVID-19
Omicron COVID-19 variant
MRNA
Pfizer
Moderna Therapeutics
Amid JAK debacle, Bristol Myers settles in for FDA's long review of potential first TYK2 drug
Endpoints
Mon, 11/29/21 - 11:09 am
Bristol Myers Squibb
FDA
deucravacitinib
Who Would Be the Best FDA Commissioner for Biotech Investors?
Motley Fool
Sun, 11/28/21 - 10:48 pm
FDA
regulatory
Robert Califf
Janet Woodcock
New Merck study results raise questions about its COVID-19 pill
BioPharma Dive
Fri, 11/26/21 - 08:55 pm
Merck
COVID-19
FDA
molnupiravir
antivirals
FDA clears Takeda drug for post-transplant CMV infections
Pharmaforum
Wed, 11/24/21 - 10:06 am
Takeda
FDA
post-transplant CMV
Livtencity
maribavir

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