FDA

FDA finalizes accelerated approval labeling guidance
FDA finalizes accelerated approval labeling guidance
Endpoints
FDA
labeling
Flag link:
FDA slaps a clinical hold on messenger RNA program for rare genetic disease
FDA slaps a clinical hold on messenger RNA program for rare genetic disease
Endpoints
Translate Bio
MRNA
FDA
Flag link:
Boston Scientific Stands Behind Its Stents in Wake of JAHA Article and FDA Investigation
Boston Scientific Stands Behind Its Stents in Wake of JAHA Article and FDA Investigation
BioSpace
devices
Boston Scientific
FDA
AHA
paclitaxel
stents
Flag link:
Samsung Bioepis' First Cancer Biosimilar Approved by the FDA
Samsung Bioepis' First Cancer Biosimilar Approved by the FDA
BioSpace
FDA
Samsung Bioepis
Ontruzant
biosimilars
Genentech
Herceptin
Flag link:
More FDA Furloughs Expected, Gottlieb Warns
More FDA Furloughs Expected, Gottlieb Warns
RAPS.org
FDA
Scott Gottlieb
government shutdown
Flag link:
FDA's Banner Year For Approvals: Will Market Access To New Drugs Follow Suit?
FDA's Banner Year For Approvals: Will Market Access To New Drugs Follow Suit?
Forbes
FDA
drug approvals
Flag link:
Alphabet’s smart watch ECG gets FDA backing
Alphabet’s smart watch ECG gets FDA backing
Pharmaforum
Alphabet
Verily
FDA
ECG watch
devices
Flag link:
3 Things You Need to Know About the FDA's Plan for Gene-Editing Drugs
3 Things You Need to Know About the FDA's Plan for Gene-Editing Drugs
Motley Fool
FDA
gene editing
Novartis
Sarepta Therapeutics
CAR-T
Alzheimer's disease
Flag link:
3 Potential New Drugs Held Up by the Shutdown
3 Potential New Drugs Held Up by the Shutdown
Motley Fool
FDA
government shutdown
Aimmune Therapeutics
AR 101
Celgene
fedratinib
Bristol-Myers Squibb
ozanimod
Flag link:
FDA Approves 17th Biosimilar, Third for Herceptin
FDA Approves 17th Biosimilar, Third for Herceptin
RAPS.org
FDA
Merck
Samsung Bioepis
Ontruzant
biosimilars
Roche
Herceptin
Flag link:
FDA chief Scott Gottlieb warns 'we have many hard decisions ahead of us' if government shutdown persists
FDA chief Scott Gottlieb warns 'we have many hard decisions ahead of us' if government shutdown persists
CNBC
FDA
government shutdown
Scott Gottlieb
Flag link:
FDA Launches Probe into Drug-containing Balloons, Stents
FDA Launches Probe into Drug-containing Balloons, Stents
RAPS.org
paclitaxel
FDA
drug-eluting stents
drug-containing balloons
devices
Flag link:
FDA advisers divided on Sanofi’s oral type 1 diabetes drug
FDA advisers divided on Sanofi’s oral type 1 diabetes drug
Pharmaforum
Sanofi
Lexicon Pharmaceuticals
type 1 diabetes
Zynquista
FDA
advisory panels
sotagliflozin
Flag link:
FDA rejects Immunomedics breast cancer drug, extending long regulatory drought
FDA rejects Immunomedics breast cancer drug, extending long regulatory drought
Stat
Immunomedics
FDA
breast cancer
sacituzumab govitecan
Flag link:
FDA’s Gottlieb Adds Confusion to Aimmune’s Claims of Shutdown Delay
FDA’s Gottlieb Adds Confusion to Aimmune’s Claims of Shutdown Delay
Xconomy
Aimmune Therapeutics
FDA
Scott Gottlieb
government shutdown
Flag link:
Amgen's once-dismissed osteoporosis drug Evenity 'back in the game' after rosy FDA panel vote
Amgen's once-dismissed osteoporosis drug Evenity 'back in the game' after rosy FDA panel vote
Fierce Pharma
Amgen
osteoporosis
Evenity
romosozumab
FDA
advisory panels
Flag link:
FDA Approves First Generic Version of Lundbeck’s Sabril
FDA Approves First Generic Version of Lundbeck’s Sabril
RAPS.org
FDA
Teva Pharmaceutical
Lundbeck
seizures
generics
Sabril
Vigabatrin
Flag link:
Gottlieb, Marks detail plans to advance development of cell and gene therapies
Gottlieb, Marks detail plans to advance development of cell and gene therapies
Endpoints
FDA
Scott Gottlieb
CBER
cell therapy
gene therapy
Flag link:
FDA drug reviews running on fumes
FDA drug reviews running on fumes
BioCentury
FDA
drug reviews
Scott Gottlieb
government shutdown
Flag link:
In a first, China’s BeiGene scores FDA ‘breakthrough’ status for BTK inhibitor — potential rival for Imbruvica
In a first, China’s BeiGene scores FDA ‘breakthrough’ status for BTK inhibitor — potential rival for Imbruvica
Endpoints
China
FDA
Btk inhibitors
BeiGene
cancer
Flag link:

Pages