FDA

FDA Action Alert: Regeneron, Sanofi, Celgene
FDA Action Alert: Regeneron, Sanofi, Celgene
BioSpace
FDA
drug approvals
Acer Therapeutics
Edsivo
Regeneron
Sanofi
Dupixent
Celgene
Revlimid
Alexion
Soliris
Dova Pharmaceuticals
Doptelet
Nabriva Therapeutics
Contepo
Retrophin
Thiola
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FDA Updates List of Off-Patent, Off-Exclusivity Drugs Without Generic Competition
FDA Updates List of Off-Patent, Off-Exclusivity Drugs Without Generic Competition
RAPS.org
FDA
generics
competition
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Drugmakers Call for Changes to FDA Bioavailability Guidance
Drugmakers Call for Changes to FDA Bioavailability Guidance
RAPS.org
FDA
bioavailability
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GSK wins speedy FDA Zejula review in ovarian cancer niche
GSK wins speedy FDA Zejula review in ovarian cancer niche
Fierce Pharma
GSK
FDA
Zejula
ovarian cancer
late-stage ovarian cancer
Tesaro
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AbbVie gets a green light to resume recruiting patients for one myeloma study — but Venclexta remains under a cloud
AbbVie gets a green light to resume recruiting patients for one myeloma study — but Venclexta remains under a cloud
Endpoints
AbbVie
Venclexta
Multiple Myeloma
FDA
clinical trials
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UPDATED: FDA spurns hay fever drug from India's Glenmark
UPDATED: FDA spurns hay fever drug from India's Glenmark
Endpoints
FDA
Glenmark
India
Ryaltris
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FDA proposes comparative approval standards for new opioids
FDA proposes comparative approval standards for new opioids
BioCentury
FDA
opioids
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FDA declines to approve Daiichi Sankyo's blood cancer treatment
FDA declines to approve Daiichi Sankyo's blood cancer treatment
Reuters
Daiichi Sankyo
FDA
quizartinib
acute myeloid leukemia
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FDA approves controversial women’s libido drug
FDA approves controversial women’s libido drug
Stat
FDA
female sexual dysfunction
Vyleesi
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Allergan’s Botox Approved for Pediatric Limb Spasticity Amid Split-Up Rumors
Allergan’s Botox Approved for Pediatric Limb Spasticity Amid Split-Up Rumors
Endpoints
Allergan
FDA
Botox
pediatric
upper limb spasticity
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FDA fast-tracks Alexion's Ultomiris in 2nd Soliris indication
FDA fast-tracks Alexion's Ultomiris in 2nd Soliris indication
Fierce Pharma
Alexion
Ultomiris
FDA
atypical hemolytic uremic syndrome
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Paclitaxel-Coated Devices’ Late Mortality Signal Not Well Understood, FDA Panel Hears
Paclitaxel-Coated Devices’ Late Mortality Signal Not Well Understood, FDA Panel Hears
RAPS.org
FDA
paclitaxel
devices
advisory panels
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Copycats wanted: Pfizer, AZ and more under threat as China solicits generics
Copycats wanted: Pfizer, AZ and more under threat as China solicits generics
Fierce Pharma
FDA
patents
generics
copycat drugs
China
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In starved antibiotic field, Melinta soars as FDA grants speedy drug review
In starved antibiotic field, Melinta soars as FDA grants speedy drug review
Endpoints
Melinta Therapeutics
antibiotics
Baxdela
community-acquired bacterial pneumonia
FDA
priority review
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Is sexual desire a medical issue? An experimental drug for women revives an intense debate
Is sexual desire a medical issue? An experimental drug for women revives an intense debate
Stat
FDA
female sexual dysfunction
bremelanotide
HSDD
Amag Pharmaceuticals
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FDA Releases New Data to Help Generic Drug Competitors
FDA Releases New Data to Help Generic Drug Competitors
RAPS.org
generics
FDA
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Jazz plans early July launch for sleepiness med Sunosi after DEA scheduling
Jazz plans early July launch for sleepiness med Sunosi after DEA scheduling
Fierce Pharma
Jazz Pharmaceuticals
FDA
Sunosi
DEA
narcolepsy
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The Week Ahead In Biotech: Conferences, PDUFA Dates Clinical Trial Readouts And IPOs
The Week Ahead In Biotech: Conferences, PDUFA Dates Clinical Trial Readouts And IPOs
Yahoo/Benzinga
FDA
Merck
Arqule
Affimed
BeiGene
Epizyme
MorphoSys
Theravance
Allena Pharma
Akero Therapeutics
Atreca
Dermavant Sciences
Personalis
Prevail Therapeutics
Stoke Therapeutics
IPOs
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FDA Received 6,000 Reports About Essure in 2018
FDA Received 6,000 Reports About Essure in 2018
Medical Devices and Diagnostics Industry
devices
FDA
Essure
Bayer
contraceptives
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GBT sickle cell trial hits endpoint ahead of NDA filing
GBT sickle cell trial hits endpoint ahead of NDA filing
Fierce Biotech
Global Blood Therapeutics
sickle cell disease
FDA
voxelotor
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