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FDA
Bristol Myers Squibb's CAR-T liso-cel wins long-delayed FDA nod
Bristol Myers Squibb's CAR-T liso-cel wins long-delayed FDA nod
Fierce Pharma
FDA
Bristol-Myers Squibb
liso-cel
CAR-T
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Woodcock: FDA plans guidance to address new COVID-19 variants
Woodcock: FDA plans guidance to address new COVID-19 variants
RAPS.org
FDA
COVID-19
pandemic
vaccines
drug developments
diagnostics
Janet Woodcock
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PTC aims again for FDA review of Duchenne drug despite latest miss
PTC aims again for FDA review of Duchenne drug despite latest miss
BioPharma Dive
PTC Therapeutics
Translarna
Duchenne Muscular Dystrophy
FDA
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FDA weighs tighter restrictions for Pfizer's Xeljanz on the heels of safety red flags
FDA weighs tighter restrictions for Pfizer's Xeljanz on the heels of safety red flags
Fierce Pharma
Pfizer
Xeljanz
FDA
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Novavax Initiates Rolling Review for Vaccine & Other COVID News
Novavax Initiates Rolling Review for Vaccine & Other COVID News
BioSpace
Novavax
vaccines
COVID-19
UK
Canada
FDA
NVX-CoV2373
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FDA arranges Feb. 26 AdComm to discuss J&J COVID-19 vaccine EUA
FDA arranges Feb. 26 AdComm to discuss J&J COVID-19 vaccine EUA
Fierce Biotech
FDA
JNJ
advisory panels
vaccines
COVID-19
Emergency Use Authorization
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FDA holds back from action over Xeljanz safety study FDA holds back from action over Xeljanz safety study
FDA holds back from action over Xeljanz safety study FDA holds back from action over Xeljanz safety study
Pharmaforum
Pfizer
FDA
Xeljanz
rheumatoid arthritis
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J&J asks FDA for emergency clearance of coronavirus vaccine
J&J asks FDA for emergency clearance of coronavirus vaccine
BioPharma Dive
JNJ
vaccines
COVID-19
FDA
Emergency Use Authorization
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FDA Approves First Prosthetic Implant for Above-Knee Amputees
FDA Approves First Prosthetic Implant for Above-Knee Amputees
Medical Devices and Diagnostics Industry
devices
Integrum
OPRA Implant System
FDA
prosthetics
above-knee amputees
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FDA appoints first medical device cybersecurity chief
FDA appoints first medical device cybersecurity chief
Medtech Dive
FDA
devices
cybersecurity
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AbbVie's immunology newbies Skyrizi and Rinvoq pick up the slack from declining Humira, but safety questions dog execs
AbbVie's immunology newbies Skyrizi and Rinvoq pick up the slack from declining Humira, but safety questions dog execs
Fierce Pharma
AbbVie
FDA
Skyrizi
Rinvoq
Humira
earnings
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FDA Approves Merck KGaA's Tepmetko for Aggressive Lung Cancer
FDA Approves Merck KGaA's Tepmetko for Aggressive Lung Cancer
BioSpace
Merck KGaA
Tepmetko
FDA
metastatic non-small cell lung cancer
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FDA Hit Record Drug and Biologic Approvals in 2020, Despite Ongoing Pandemic
FDA Hit Record Drug and Biologic Approvals in 2020, Despite Ongoing Pandemic
BioSpace
COVID-19
pandemic
FDA
drug approvals
biologics
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The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
Drug Patent Watch
regulatory
biosimilars
Europe
EMA
FDA
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Bristol Myers Squibb turns in priority review voucher for supplemental indication on an old Celgene drug
Bristol Myers Squibb turns in priority review voucher for supplemental indication on an old Celgene drug
Endpoints
Bristol-Myers Squibb
Celgene
FDA
ulcerative colitis
priority review
Zeposia
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Novavax and Johnson & Johnson Seek Regulatory Approval for COVID-19 Vaccines After Posting Promising Efficacy Data
Novavax and Johnson & Johnson Seek Regulatory Approval for COVID-19 Vaccines After Posting Promising Efficacy Data
Xtalks
JNJ
Novavax
COVID-19
vaccines
FDA
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Durect's non-opioid painkiller brushes aside checkered past, gaining FDA approval in shoulder surgeries
Durect's non-opioid painkiller brushes aside checkered past, gaining FDA approval in shoulder surgeries
Endpoints
Durect
FDA
non-opioid pain treatments
Posimir
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FDA Action Alert: Adamas, Mallinckrodt and Merck
FDA Action Alert: Adamas, Mallinckrodt and Merck
BioSpace
FDA
Adamas Pharmaceuticals
Mallinckrodt
Merck
Gocovri
StrataGraft
Keytruda
triple negative breast cancer
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Incyte makes bid to join the checkpoint inhibitor club
Incyte makes bid to join the checkpoint inhibitor club
Pharmaforum
Incyte
FDA
retifanlimab
anal cancer
HIV
HPV
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Here’s Why the Approval of Lupkynis Has Biotech Investors Buzzing
Here’s Why the Approval of Lupkynis Has Biotech Investors Buzzing
Xtalks
FDA
Aurinia Pharmaceuticals
Lupkynis
voclosporin
lupus nephritis
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