FDA

BeyondSpring is laying off 35% of staff in wake of FDA rejection of lead drug
MedCity News
Thu, 01/13/22 - 07:18 am
BeyondSpring
FDA
layoffs
plinabulin
Woodcock defends FDA's response to Omicron before Senate health committee
Endpoints
Wed, 01/12/22 - 10:47 am
FDA
Janet Woodcock
COVID-19
Senate
Omicron COVID-19 variant
5 questions facing the FDA in 2022
BioPharma Dive
Tue, 01/11/22 - 10:20 pm
FDA
regulatory
Robert Califf
Biogen
Aduhelm
23andMe Keeps Snagging FDA Nods for Cancer Marker Tests
Medical Devices and Diagnostics Industry
Tue, 01/11/22 - 10:15 pm
23andMe
FDA
diagnostics
prostate cancer
cancer
Idorsia scores FDA go-ahead for insomnia drug Quviviq to rival Merck’s Belsomra, Eisai’s Dayvigo
Fierce Pharma
Mon, 01/10/22 - 11:37 pm
Idorsia
Quviviq
insomnia
FDA
Merck
Belsomra
U.S. Could Authorize Novavax Covid Vaccine—An MRNA Alternative—In February, CEO Says
Forbes
Mon, 01/10/22 - 11:35 pm
Novavax
COVID-19
vaccines
FDA
AbbVie seeks approval for upadacitinib to treat nr-axSpA
Pharmaceutical Business Review
Mon, 01/10/22 - 11:29 am
AbbVie
FDA
EMA
upadacatinib
nr-axSpA
non-radiographic axial spondyloarthritis
A late Christmas present for Allogene
EP Vantage
Mon, 01/10/22 - 11:27 am
Allogene
JPMHC 2022
FDA
CAR-T
Judge: FDA Cannot Have Until 2076 to Disclose Pfizer/BioNTech Vaccine Data
BioSpace
Fri, 01/7/22 - 10:52 am
FDA
Pfizer
vaccines
COVID-19
legal
FDA Decision on Senseonics' 180-Day CGM Expected in Coming Weeks
Medical Devices and Diagnostics Industry
Thu, 01/6/22 - 12:34 pm
devices
Medtech
Senseonics
continuous glucose monitoring
Eversense
diabetes
FDA
FDA pauses domestic drug inspections again, this time to protect against Omicron
Endpoints
Wed, 01/5/22 - 10:36 am
FDA
inspections
regulatory
COVID-19
Omicron COVID-19 variant
FDA grants breakthrough designation to AbbVie’s Teliso-V for NSCLC treatment
Pharmaceutical Business Review
Wed, 01/5/22 - 10:33 am
FDA
AbbVie
Teliso-V
telisotuzumab vedotin
non-small cell lung cancer
Robert Califf is a fervent believer in data. At the FDA, will that be enough?
Stat
Wed, 01/5/22 - 10:31 am
FDA
Robert Califf
regulatory
FDA approves Immix Biopharma Rare Pediatric Disease Designation for cancer treatment
Biopharma Reporter
Tue, 01/4/22 - 10:48 am
Immix Bio
FDA
IMX-110
rhabdomyosarcoma
pediatric
3 Biotech Stocks With Major Catalysts in January
Motley Fool
Tue, 01/4/22 - 10:25 am
Novavax
vaccines
COVID-19
FDA
Intercept Pharma
Ocaliva
NASH
Madrigal Pharmaceuticals
resmetirom
Applied Therapeutics pulls plans to file accelerated approval after FDA 'change in direction' — shares plummet
Endpoints
Tue, 01/4/22 - 10:22 am
Applied Therapeutics
FDA
galactosemia
AT-007
FDA authorizes the first at-home pills from Pfizer to treat Covid-19
Endpoints
Mon, 01/3/22 - 10:51 pm
Pfizer
FDA
nirmatrelvir
ritonavir
Biogen and Eisai move forward with investigational Alzheimer's therapy
Biopharma Reporter
Mon, 01/3/22 - 10:45 pm
Biogen
Eisai
lecanemab
Alzheimer's disease
fast track
FDA
Interval between Moderna COVID-19 vaccine second shot and booster still six months -FDA
Yahoo/Reuters
Mon, 01/3/22 - 10:43 pm
Moderna Therapeutics
COVID-19
boosters
vaccines
FDA
FDA authorizes first Covid-19 booster shot for teens aged 12 to 15
Stat
Mon, 01/3/22 - 10:50 am
FDA
Pfizer
BioNTech
vaccines
boosters
COVID-19

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