FDA

Breast Implant Manufacturers Draw FDA Warning Letters Over Post-Approval Studies
Breast Implant Manufacturers Draw FDA Warning Letters Over Post-Approval Studies
RAPS.org
FDA
warnings
breast implants
devices
JNJ
Mentor
Sientra
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Jazz Pharma's sleep disorder treatment gets FDA nod
Jazz Pharma's sleep disorder treatment gets FDA nod
Yahoo/Reuters
Jazz Pharma
FDA
solriamfetol
narcolepsy
obstructive sleep apnea
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Roche’s Tecentriq gains new US lung cancer indication
Roche’s Tecentriq gains new US lung cancer indication
Pharmaforum
Roche
Genentech
Tecentriq
FDA
extensive-stage small cell lung cancer
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AbbVie stock down 0.8% after FDA places hold on clinical trials of venetoclax as a treatment for multiple myeloma
AbbVie stock down 0.8% after FDA places hold on clinical trials of venetoclax as a treatment for multiple myeloma
Marketwatch
AbbVie
venetoclax
Multiple Myeloma
FDA
clinical trials
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Allergan's NDA for Migraine Med With Novel Mechanism of Action Accepted by FDA
Allergan's NDA for Migraine Med With Novel Mechanism of Action Accepted by FDA
BioSpace
Allergan
migraines
ubrogepant
FDA
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Behind the Numbers: FDA Offers Budget Specifics, New Proposals
Behind the Numbers: FDA Offers Budget Specifics, New Proposals
RAPS.org
FDA
opioid crisis
generics
devices
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Pharma ad police issues 2019's first warning over promotion of unapproved imaging drug
Pharma ad police issues 2019's first warning over promotion of unapproved imaging drug
Fierce Pharma
FDA
warning letters
OPDP
Phoenix Molecular Imaging
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FDA’s CDRH reorganization plans to launch next Monday
FDA’s CDRH reorganization plans to launch next Monday
Mass Device
FDA
Radiology
devices
CDRH
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FDA ramps up scrutiny of materials in medical devices
FDA ramps up scrutiny of materials in medical devices
Mass Device
FDA
devices
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Scott Gottlieb to biopharma: You wanted us to help modernize R&D, now go out and do it
Scott Gottlieb to biopharma: You wanted us to help modernize R&D, now go out and do it
Endpoints
FDA
R&D
Scott Gottlieb
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Spectrum yanks marketing application for Neulasta rival after FDA demands more data
Spectrum yanks marketing application for Neulasta rival after FDA demands more data
Endpoints
Spectrum Pharmaceuticals
FDA
lung cancer
poziotinib
Neulasta
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Karyopharm gets bump as FDA extends review of selinexor
Karyopharm gets bump as FDA extends review of selinexor
BioCentury
Karyopharm
FDA
Selinexor
Multiple Myeloma
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FDA approves valsartan generic amid probe into impurities
FDA approves valsartan generic amid probe into impurities
Biopharma Dive
FDA
hypertension
generics
Valsartan
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J&J Seeks Approval for Darzalex in Expanded Patient Group
J&J Seeks Approval for Darzalex in Expanded Patient Group
Yahoo/Zacks.com
JNJ
Darzalex
Multiple Myeloma
FDA
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Gottlieb pushes out more guidances on modernizing trials
Gottlieb pushes out more guidances on modernizing trials
BioCentury
FDA
Scott Gottlieb
clinical trials
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Industry insiders offer a big thumbs-up for Ned Sharpless
Industry insiders offer a big thumbs-up for Ned Sharpless
Endpoints
FDA
Ned Sharpless
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FDA Warning Letters: An Overview of 2019’s Letters So Far
FDA Warning Letters: An Overview of 2019’s Letters So Far
BioSpace
FDA
warning letters
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FDA qualifies first biomarker test for brain injury
FDA qualifies first biomarker test for brain injury
BioCentury
FDA
traumatic brain injury
diagnostics
biomarkers
OsiriX
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FDA Clears Aerie’s Combo Glaucoma Drug, But Will it Sell?
FDA Clears Aerie’s Combo Glaucoma Drug, But Will it Sell?
Xconomy
Aerie Pharma
glaucoma
FDA
Rocklatan
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FDA looks to broaden cancer trial eligibility
FDA looks to broaden cancer trial eligibility
BioCentury
FDA
cancer
clinical trials
oncology
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