FDA

Teva Confirms September PDUFA Date for Fremanezumab
Teva Confirms September PDUFA Date for Fremanezumab
CP Wire
Teva
fremanezumab
migraine
episodic migraines
FDA
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House passes “right-to-try” — allowing the terminally ill to ask companies for experimental drugs outside of FDA’s purview
House passes “right-to-try” — allowing the terminally ill to ask companies for experimental drugs outside of FDA’s purview
Biopharma Dive
right-to-try laws
FDA
Senate
congress
regulatory
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FDA plans to speed path to approval for some gene therapies, starting with hemophilia
FDA plans to speed path to approval for some gene therapies, starting with hemophilia
Stat
FDA
drug approvals
gene therapies
Scott Gottlieb
hemophilia
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Will Amgen’s migraine win and 5th thumbs-up for Prolia drive enough growth? Nope, says analyst
Will Amgen’s migraine win and 5th thumbs-up for Prolia drive enough growth? Nope, says analyst
Fierce Pharma
Amgen
FDA
Aimovig
migraines
Prolia
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FDA approves first TPO agonist for chronic liver disease
FDA approves first TPO agonist for chronic liver disease
Biopharma Dive
FDA
Dova Pharmaceuticals
Doptelet
chronic liver disease
thrombocytopenia
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Alzheimer’s Disease: Companies Weigh Revised FDA Draft Guidance
Alzheimer’s Disease: Companies Weigh Revised FDA Draft Guidance
RAPS.org
Alzheimer's disease
FDA
Roche
AstraZeneca
Bioclinica
Eli Lilly
Denali Therapeutics
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FDA warns of decreased survival in 2 studies of Keytruda, Tecentriq
FDA warns of decreased survival in 2 studies of Keytruda, Tecentriq
Biopharma Dive
FDA
clinical trials
oncologists
bladder cancer
Merck
Keytruda
Roche
Tecentriq
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GSK’s Arnuity Ellipta asthma therapy wins FDA nod for use in kids as young as 5 years old
GSK’s Arnuity Ellipta asthma therapy wins FDA nod for use in kids as young as 5 years old
Drug Delivery Business News
GSK
FDA
Arnuity Ellipta
asthma
pediatric
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Beta receives FDA go-ahead for home trials of AI-guided bionic pancreas
Beta receives FDA go-ahead for home trials of AI-guided bionic pancreas
Fierce Biotech
Beta Bionics
FDA
bionic pancreas
artificial intelligence
devices
type 1 diabetes
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FDA Accepts NDA for Aemcolo (Rifamycin SV MMX) for Travelers' Diarrhea
FDA Accepts NDA for Aemcolo (Rifamycin SV MMX) for Travelers' Diarrhea
CP Wire
Cosmo Pharma
Aemcolo
traveler's diarrhea
fast track
FDA
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AstraZeneca potassium drug finally approved, threatening Vifor
AstraZeneca potassium drug finally approved, threatening Vifor
Yahoo/Reuters
AstraZeneca
Lokelma
hyperkalemia
ZS-9
Vifor
Valtessa
FDA
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This Cannabis-Based Drug Is On the Verge of Making History
This Cannabis-Based Drug Is On the Verge of Making History
Motley Fool
GW Pharma
Epidiolex
CBD
Dravet syndrome
Lennox-Gastaut Syndrome
FDA
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FDA executes an abrupt about-face as sole-source contract for ex-agency chief Mark McClellan draws the spotlight
FDA executes an abrupt about-face as sole-source contract for ex-agency chief Mark McClellan draws the spotlight
Endpoints
FDA
Scott Gottlieb
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Agile bristles after FDA’s third snub, promising a fight for its contraceptive
Agile bristles after FDA’s third snub, promising a fight for its contraceptive
Endpoints
Agile Therapeutics
FDA
contraceptive patch
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Regulators flag possible birth defect link to GSK's HIV drug
Regulators flag possible birth defect link to GSK's HIV drug
Yahoo/Reuters
GSK
HIV
Dolutegravir
birth defects
EMA
FDA
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FDA looking at ways to include price info in drug ads, Gottlieb says, as questions loom
FDA looking at ways to include price info in drug ads, Gottlieb says, as questions loom
Stat
FDA
Scott Gottlieb
drug pricing
drug ads
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Amgen's Aimovig won its first-in-class migraine nod. Will payers step up to the $6,900 price?
Amgen's Aimovig won its first-in-class migraine nod. Will payers step up to the $6,900 price?
Fierce Pharma
Amgen
Novartis
Aimovig
FDA
migraines
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FDA clears Additive Ortho’s patient specific 3D printed bone segments
FDA clears Additive Ortho’s patient specific 3D printed bone segments
Mass Device
Additive Orthopaedics
FDA
3D-printed medical devices
bone fixation
devices
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Right-to-try bill headed for vote puts bigger burden on FDA to protect patients, Gottlieb says
Right-to-try bill headed for vote puts bigger burden on FDA to protect patients, Gottlieb says
Stat
FDA
right-to-try laws
Scott Gottlieb
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FDA calls out 39 drug companies for allegedly blocking access to generics
FDA calls out 39 drug companies for allegedly blocking access to generics
Stat
JNJ
Actelion
Celgene
Gilead
Novartis
Pfizer
Valeant Pharmaceuticals
generics
FDA
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