FDA

FDA approves oral formulation of old ALS drug, giving patients new treatment option in sorely needed field
Endpoints
Fri, 05/13/22 - 10:41 am
Mitsubishi Tanabe Pharma
ALS
Radicava
FDA
FDA approves new indication for drug to treat severe COVID-19
Beckers Hospital Review
Thu, 05/12/22 - 10:51 pm
Eli Lilly
Incyte
baricitinib
FDA
olumiant
COVID-19
Medtronic aims to improve the colonoscopy with AI
MedCity News
Thu, 05/12/22 - 10:16 am
devices
Medtech
artificial intelligence
Colonoscopy
FDA
Medtronic
FDA’s CDER Introduces New ARC Program to Accelerate Rare Disease Cures
Xtalks
Wed, 05/11/22 - 10:41 pm
FDA
CDER
ARC program
Rare Diseases
Can FDA replicate Operation Warp Speed for rare diseases? Not yet, but Peter Marks has some ideas
Fierce Biotech
Wed, 05/11/22 - 10:29 am
FDA
Peter Marks
CBER
gene therapy
cell therapy
Operation Warp Speed
Rare Diseases
Researchers Use Emerging Ovarian Cancer Biomarker to Develop New Blood Test for Ovarian Cancer
Xtalks
Tue, 05/10/22 - 10:41 am
diagnostics
ovarian cancer
biomarkers
FDA
FDA's Peter Marks to Congress: Youngest kids vaccine won't need to hit 50% efficacy mark
Endpoints
Mon, 05/9/22 - 10:09 am
FDA
congress
Peter Marks
vaccines
COVID-19
pediatric
VistaGen says regulators couldn’t sniff out abuse potential of its nasal spray for social anxiety
Fierce Biotech
Sun, 05/8/22 - 12:14 pm
VistaGen
social anxiety
PH94B
clinical trials
FDA
Clovis quietly unveils crippling FDA delay as its troubles deepen
Fierce Pharma
Fri, 05/6/22 - 11:05 am
Clovis Oncology
FDA
Rubraca
ovarian cancer
FDA to create training program to inspect more mRNA vaccine manufacturing
Endpoints
Fri, 05/6/22 - 10:49 am
FDA
MRNA
training
regulatory
Amylyx Augments Case for ALS Drug Ahead of PDUFA Date
BioSpace
Thu, 05/5/22 - 11:30 pm
Amylx
AMX0035
ALS
FDA
FDA Approves AstraZeneca, Daiichi Sankyo’s ENHERTU in Breast Cancer
Contract Pharma
Thu, 05/5/22 - 10:40 am
AstraZeneca
Daiichi Sankyo
Enhertu
FDA
HER2+ breast cancer
breast cancer
AZ eyes Q3 FDA decision for Imfinzi in biliary tract cancer
Pharmaforum
Thu, 05/5/22 - 10:38 am
AstraZeneca
Imfinzi
biliary tract cancer
FDA
priority review
FDA Approvals Roundup: Camzyos, Vivjoa, Epsolay
RAPS.org
Thu, 05/5/22 - 10:23 am
FDA
drug approvals
Bristol Myers Squibb
Camzyos
Mycovia
Vivjoa
Sol-Gel
Epsolay
FDA rebukes Pfizer CEO’s suggestion to take more Paxlovid if COVID-19 symptoms return
Fierce Pharma
Wed, 05/4/22 - 05:46 pm
Pfizer
Albert Bourla
Pharma CEOs
FDA
Paxlovid
COVID-19
FDA officials: ‘New normal’ may include annual COVID vaccination
RAPS.org
Wed, 05/4/22 - 10:36 am
FDA
vaccines
COVID-19
How Bad Is This News for Vertex Pharmaceuticals?
Motley Fool
Wed, 05/4/22 - 10:28 am
Vertex Pharmaceuticals
VX-880
type 1 diabetes
FDA
Another Pfizer gene therapy is free of FDA hold, but delay continues
Fierce Biotech
Tue, 05/3/22 - 10:53 pm
Pfizer
FDA
clinical trials
hemophilia A
gene therapy
giroctocogene fitelparvovec
Sangamo Therapeutics
FDA's use of adcomms prior to drug approval decreased over the last decade
RAPS.org
Tue, 05/3/22 - 10:49 pm
FDA
regulatory
advisory panels
drug approvals
Exclusive: Connect Biopharma reports a PhII fail for Zeposia challenger, and execs appear ready to punt
Endpoints
Tue, 05/3/22 - 10:46 pm
Connect Biopharma
Pfizer
Bristol Myers Squibb
FDA
clinical trials
ulcerative colitis
CBP-307

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