FDA

One year after Fetroja approval, Shionogi expands label to include difficult-to-treat pneumonia
One year after Fetroja approval, Shionogi expands label to include difficult-to-treat pneumonia
Endpoints
Fetroja
Shionogi
hospital-acquired pneumonia
ventilator-associated bacterial pneumonia
FDA
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Generic drugmakers get guidance on tentative approvals, CRLs
Generic drugmakers get guidance on tentative approvals, CRLs
RAPS.org
FDA
regulatory
generics
ANDAs
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Scientists urge Pfizer to delay COVID-19 vaccine filing
Scientists urge Pfizer to delay COVID-19 vaccine filing
Pharmaforum
FDA
COVID-19
vaccines
Pfizer
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GlaxoSmithKline's Nucala targets rival AstraZeneca with FDA nod for rare white blood cell disease
GlaxoSmithKline's Nucala targets rival AstraZeneca with FDA nod for rare white blood cell disease
Fierce Pharma
GSK
Nucala
hypereosinophilic syndrome
FDA
AstraZeneca
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FDA, HHS allow states to import drugs from Canada
FDA, HHS allow states to import drugs from Canada
Beckers Hospital Review
FDA
HHS
Canada
drug importation
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Another strong year for novel drug approvals is in the making
Another strong year for novel drug approvals is in the making
EP Vantage
FDA
drug approvals
regulatory
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FDA fast-tracks Leap’s gastric cancer immunotherapy
FDA fast-tracks Leap’s gastric cancer immunotherapy
Pharmaforum
Leap Therapeutics
FDA
DKN-01
priority review
gastric cancer
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FDA Will Allow At-Home Administration of Capsule Endoscope During COVID-19
FDA Will Allow At-Home Administration of Capsule Endoscope During COVID-19
Medical Devices and Diagnostics Industry
FDA
CapsoVision
CapsoCam Plus
endocopy
endoscopes
capsule endoscopes
devices
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Moderna's COVID-19 vaccine investigator leaves FDA advisory committee over conflict of interest
Moderna's COVID-19 vaccine investigator leaves FDA advisory committee over conflict of interest
Fierce Biotech
Moderna Therapeutics
COVID-19
vaccines
FDA
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FDA proposes change to rule on off-label drug use
FDA proposes change to rule on off-label drug use
Stat
FDA
off-label
regulatory
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FDA creates Digital Health Center of Excellence
FDA creates Digital Health Center of Excellence
MedCity News
FDA
digital health
regulatory
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FDA sets back Novartis plans to expand use of SMA gene therapy
FDA sets back Novartis plans to expand use of SMA gene therapy
BioPharma Dive
Novartis
SMA
gene therapy
Zolgensma
clinical trials
FDA
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Cognoa Makes Push to Get FDA Nod for Digital Autism Diagnostic
Cognoa Makes Push to Get FDA Nod for Digital Autism Diagnostic
Medical Devices and Diagnostics Industry
Cognoa
FDA
devices
digital diagnostics
autism
diagnostics
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Under fire, FDA to issue stricter guidance for Covid-19 vaccine EUA this week — report
Under fire, FDA to issue stricter guidance for Covid-19 vaccine EUA this week — report
Endpoints
FDA
vaccines
COVID-19
Emergency Use Authorization
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Blueprint plots return to FDA with new Ayvakit data in rare condition — and the analysts cheer
Blueprint plots return to FDA with new Ayvakit data in rare condition — and the analysts cheer
Endpoints
Blueprint Medicines
Roche
FDA
Ayvakit
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OptumRx's 3 recently approved drugs to watch
OptumRx's 3 recently approved drugs to watch
Beckers Hospital Review
FDA
Kite Pharma
Tecartus
Novartis
Kesimpta
MorphoSys
Monjuvi
OptumRx
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Medtronic Wins Breakthrough Device Designation for TYRX
Medtronic Wins Breakthrough Device Designation for TYRX
Medical Devices and Diagnostics Industry
Medtronic
devices
FDA
breakthrough device
Tyrx
ventricular assist devices
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FDA grants priority review to ide-cel, keeping Bristol Myers on track to deliver Celgene payday
FDA grants priority review to ide-cel, keeping Bristol Myers on track to deliver Celgene payday
Fierce Biotech
Bristol-Myers Squibb
Celgene
Bluebird Bio
FDA
priority review
ide-cel
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IPO, check: Now, ADC Therapeutics files for lonca approval
IPO, check: Now, ADC Therapeutics files for lonca approval
Fierce Biotech
ADC Therapeutics
IPOs
FDA
loncastuximab
diffuse large B-cell lymphoma
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La FDA, c’est moi: In memo, HHS’ Azar asserts power to sign new rules, traditionally purview of agencies’ lawyers
La FDA, c’est moi: In memo, HHS’ Azar asserts power to sign new rules, traditionally purview of agencies’ lawyers
MedCity News
HHS
FDA
Alex Azar
regulatory
COVID-19
pandemic
vaccines
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