FDA

Report: FDA panel wants more extensive data, quality of life outcomes for vaginal mesh products
Report: FDA panel wants more extensive data, quality of life outcomes for vaginal mesh products
Mass Device
FDA
devices
transvaginal mesh
pelvic mesh
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FDA funding set to jump as Congress votes to avert shutdown
FDA funding set to jump as Congress votes to avert shutdown
Fierce Biotech
FDA
congress
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Keytruda-Inlyta combo under Priority Review for first-line RCC
Keytruda-Inlyta combo under Priority Review for first-line RCC
BioCentury
Merck
Keytruda
Inlyta
renal cell carcinoma
FDA
priority review
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A record year for device innovation
A record year for device innovation
Mass Device
FDA
devices
innovation
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Liver toxicity concerns spike Motif Bio’s iclaprim filing
Liver toxicity concerns spike Motif Bio’s iclaprim filing
Fierce Biotech
FDA
Motif Biosciences
ABSSSI
Iclaprim
complete response letter
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Drugmakers Debate Whether Parts of FDA’s Biosimilar Guidance are Unconstitutional
Drugmakers Debate Whether Parts of FDA’s Biosimilar Guidance are Unconstitutional
RAPS.org
FDA
biosimilars
BLA
NDA
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Novartis secures regulatory 'fast pass' in US OK for tropical disease drug
Novartis secures regulatory 'fast pass' in US OK for tropical disease drug
Biopharma Dive
Novartis
FDA
Egaten
fast pass
priority review
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FDA Updates List of Brand Name Companies Blocking Generic Applicants
FDA Updates List of Brand Name Companies Blocking Generic Applicants
RAPS.org
FDA
Scott Gottlieb
competition
generics
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FDA experts offer a big thumbs up for J&J’s flawed application to market esketamine for major depression — but trial failures, safety questions spur concerns
FDA experts offer a big thumbs up for J&J’s flawed application to market esketamine for major depression — but trial failures, safety questions spur concerns
Endpoints
JNJ
FDA
advisory panels
esketamine
major depression
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FDA promises speedy review on moving Merck's Keytruda up as first-line head and neck cancer therapy
FDA promises speedy review on moving Merck's Keytruda up as first-line head and neck cancer therapy
Endpoints
Merck
Keytruda
FDA
head and neck cancer
priority review
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Approving J&J's new depression drug would be an unusual move for the FDA
Approving J&J's new depression drug would be an unusual move for the FDA
BioPharma Dive
JNJ
esketamine
FDA
advisory panels
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Incyte Down as FDA Extends Review Period of Jakafi for GVHD
Incyte Down as FDA Extends Review Period of Jakafi for GVHD
Yahoo/Zacks.com
Incyte
FDA
Jakafi
graft vs host disease
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J&J’s Esketamine for Depression Faces an FDA Panel Next Week
J&J’s Esketamine for Depression Faces an FDA Panel Next Week
BioSpace
JNJ
FDA
esketamine
major depression
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Immunomedics, still searching for first approval, discloses forthcoming FDA re-inspection
Immunomedics, still searching for first approval, discloses forthcoming FDA re-inspection
Biopharma Dive
Immunomedics
FDA
sacituzumab govitecan
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FDA Raises Concerns With 505(q) Petitions
FDA Raises Concerns With 505(q) Petitions
RAPS.org
FDA
Public Health
505(q) petitions
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FDA clears AI wearable to monitor hospital patients
FDA clears AI wearable to monitor hospital patients
Pharmaforum
artificial intelligence
wearables
devices
Current Health
FDA
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Daiichi gets speedy FDA review for rare cancer drug
Daiichi gets speedy FDA review for rare cancer drug
Pharmaforum
Daiichi Sankyo
FDA
pexidartinib
TGCT
priority review
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Pulmatrix wins FDA nod for PhII trial of inhaled anti-fungal therapy
Pulmatrix wins FDA nod for PhII trial of inhaled anti-fungal therapy
Drug Delivery Business News
Pulmatrix
FDA
anti-fungal
itraconazole
asthma
allergic bronchopulmonatry aspergillosis
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Rare pediatric PRV program not linked to uptick in new drugs starting trials, study finds
Rare pediatric PRV program not linked to uptick in new drugs starting trials, study finds
Forbes
FDA
clinical trials
priority review vouchers
pediatrics
pediatric rare diseases
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FDA approves Sanofi's Cablivi for rare clotting disease
FDA approves Sanofi's Cablivi for rare clotting disease
BioCentury
Sanofi
Cablivi
aTTP
FDA
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